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Prone Positioning in Awake, Nonintubated Patients With COVID-19 Hypoxemic Respiratory Failure

Prone Positioning in Awake, Nonintubated Patients With COVID-19 Hypoxemic Respiratory Failure Letters Conflict of Interest Disclosures: Dr Redberg receives research funding from as inappropriate for PCI (13% of all cases). Notably, this figure the Arnold Ventures Foundation, Greenwall Foundation, Flight Attendant likely greatly underestimates the number of inappropriate PCIs Medical Research Institute, and National Institutes of Health. No other because the authors were unable to determine if sympto- disclosures are reported. matic patients had first tried and failed optimal medical man- 1. Grady D, Redberg RF. Less is more: how less health care can result in better agement before undergoing PCI. health. Arch Intern Med. 2010;170(9):749-750. doi:10.1001/archinternmed. 2010.90 Although robust guidelines should be expected to reduce in- 2. Malik AO, Spertus JA, Patel MR, et al. Potential association of the ISCHEMIA appropriate PCI, Howard and Desai demonstrate how imple- trial with the appropriate use criteria ratings for percutaneous coronary menting such criteria depends on accurately reporting case char- intervention in stable ischemic heart disease. JAMA Intern Med. Published online acteristics (eg, the severity of coronary stenosis and symptoms) September 21, 2020. doi:10.1001/jamainternmed.2020.3181 and highlight egregious examples for which the reporting was 3. Howard DH, Desai NR. US False Claims Act investigations of unnecessary not only inaccurate but dishonest. Specifically, they investigated percutaneous coronary interventions. JAMA Intern Med. Published online September 21, 2020. doi:10.1001/jamainternmed.2020.2812 the association of the US False Claims Act, a law that allows 4. Stergiopoulos K, Boden WE, Hartigan P, et al. Percutaneous coronary whistleblowers to raise concerns of inappropriate care, with PCI 2 intervention outcomes in patients with stable obstructive coronary artery volumesforpatientswithoutacuteMI. Between2006and2016, disease and myocardial ischemia: a collaborative meta-analysis of the authors identified 8 cases of PCI-related US False Claims Act contemporary randomized clinical trials. JAMA Intern Med. 2014;174(2):232-240. cases that became public. Compared with matched control hos- doi:10.1001/jamainternmed.2013.12855 pitals, PCI volumes for nonacute MI decreased more from 2006 5. Maron DJ, Hochman JS, Reynolds HR, et al; ISCHEMIA Research Group. Initial invasive or conservative strategy for stable coronary disease. N Engl J Med. and 2016 in hospitals subject to claims of dishonest reporting 2020;382(15):1395-1407. doi:10.1056/NEJMoa1915922 (68.4% vs 81.2%; P< .001). Although the substantial decrease in 6. Holmboe ES, Fiellin DA, Cusanelli E, Remetz M, Krumholz HM. Perceptions of PCI seen in all hospitals suggests an overall movement to a more benefit and risk of patients undergoing first-time elective percutaneous evidence-based use of PCI, the differential decrease in hospitals coronary revascularization. J Gen Intern Med. 2000;15(9):632-637. doi:10.1046/ that underwent investigations of false claims suggests that there j.1525-1497.2000.90823.x is a role for the enforcement of accurate reporting of indications 7. Rothberg MB, Sivalingam SK, Ashraf J, et al. Patients’ and cardiologists’ perceptions of the benefits of percutaneous coronary intervention for stable for PCI. It is unknown how commonly coronary stenosis is over- coronary disease. Ann Intern Med. 2010;153(5):307-313. doi:10.7326/0003- estimated in centers that have not been targeted by False Claims 4819-153-5-201009070-00005 cases. Despite the effect of these efforts, without quantitative, 8. Lin GA, Dudley RA, Redberg RF. Cardiologists’ use of percutaneous coronary objective standards for stenosis, it is likely that some overesti- interventions for stable coronary artery disease. Arch Intern Med. 2007;167 mation of coronary stenosis will remain. (15):1604-1609. doi:10.1001/archinte.167.15.1604 Reports of continued substantial rates of inappropriate PCI 9. Weintraub WS, Spertus JA, Kolm P, et al; COURAGE Trial Research Group. Effect of PCI on quality of life in patients with stable coronary disease. N Engl J provide a compelling illustration of the considerable work that Med. 2008;359(7):677-687. doi:10.1056/NEJMoa072771 remains to protect patients and the health care system from 10. Zhang H, Mu L, Hu S, et al; China PEACE Collaborative Group. Comparison the harms and costs of unnecessary PCI. As a conservative es- of physician visual assessment with quantitative coronary angiography in timate (ie, not including cases that could be averted with op- assessment of stenosis severity in China. JAMA Intern Med. 2018;178(2):239-247. timal medical management or the costs of adverse outcomes doi:10.1001/jamainternmed.2017.7821 of PCIs), if the approximately 50 000 PCI cases deemed rarely 11. Bress AP, Bellows BK, King JB, et al; SPRINT Research Group. Cost-effectiveness of intensive versus standard blood-pressure control. N Engl J appropriate by Malik et al were averted at a cost of $30 000 Med. 2017;377(8):745-755. doi:10.1056/NEJMsa1616035 per PCI, this would produce a savings of $1.5 billion annu- 12. Borden WB, Redberg RF, Mushlin AI, Dai D, Kaltenbach LA, Spertus JA. ally. However, if we extrapolate from prior work showing that Patterns and intensity of medical therapy in patients undergoing percutaneous greater than 50% of patients undergoing PCIs with stable CAD coronary intervention. JAMA. 2011;305(18):1882-1889. doi:10.1001/jama.2011.601 are not receiving optimal medical therapy, it is likely that at least 150 000 more PCI cases are inappropriate and cost sav- ings are closer to $6 billion annually. The work of these au- Prone Positioning in Awake, Nonintubated Patients thors shows a promising method of reducing unnecessary PCI With COVID-19 Hypoxemic Respiratory Failure by combining robust, unambiguous consensus guidelines with Critically ill patients with coronavirus disease 2019 (COVID-19) enforcement of accurate reporting of indications for PCI. How- severely strained intensive care resources in New York City in ever, these measures are not a cure-all in a health care system April 2020. The prone position improves oxygenation in intu- 2,3 propelled by enthusiasm for technology regardless of net ben- bated patients with acute respiratory distress syndrome. efits and rewarded with fee-for-service payments not associ- We investigated whether the ated with the appropriateness of the procedure. prone position is associated Invited Commentary with improved oxygenation page 1539 James W. Salazar, MD, MAS and decreased risk for intuba- Rita F. Redberg, MD, MSc tion in spontaneously breathing patients with severe COVID-19 4-6 hypoxemic respiratory failure. Author Affiliations: Department of Medicine, University of California, San Francisco (Salazar, Redberg); Editor, JAMA Internal Medicine (Redberg). Methods | We screened consecutive patients admitted to the Co- Published Online: September 21, 2020. doi:10.1001/jamainternmed.2020.2801 lumbia University step-down unit (intermediate care unit) be- Corresponding Author: Rita F. Redberg, MD, MSc, Department of Medicine, tween April 6 and April 14, 2020 (N = 88). Inclusion criteria were University of California, San Francisco, 505 Parnassus, M1180, San Francisco, CA 94143-0124 (rita.redberg@ucsf.edu). laboratory-confirmed COVID-19 with severe hypoxemic respi- jamainternalmedicine.com (Reprinted) JAMA Internal Medicine November 2020 Volume 180, Number 11 1537 Letters ratory failure defined as respiratory rate of 30 breaths/min or proved the study and waived the need for informed consent from greater and oxyhemoglobin saturation (SpO ) of 93% or less while the participants, as we analyzed deidentified data collected from receiving supplemental oxygen 6 L/min via nasal cannula and electronic medical records. The primary outcome was change in 15 L/min via nonrebreather face mask. A confirmed case of SpO before and 1 hour after initiation of the prone position. We COVID-19 was defined by a positive result on a reverse report the median change in SpO with 95% CIs. We used the Wil- transcriptase–polymerase chain reaction assay of a specimen col- coxon test for analysis of change in SpO . We assessed the mean lected on a nasopharyngeal swab. Exclusion criteria were altered risk difference in intubation rates for patients with SpO of 95% mental status with inability to turn in bed without assistance or greater vs SpO less than 95% 1 hour after initiation of the prone (n = 13), extreme respiratory distress requiring immediate intu- position. We assessed intubation rates across demographic and bation (n = 23), or oxygen requirements less than those specified other clinical factors with RStudio, version 1.2.5019 (RStudio). in the inclusion criteria (n = 23). We asked eligible patients (n = 29) to lie on their stomach for as long as tolerated up to 24 Results | Among 29 eligible patients, 25 had at least 1 awake ses- hours daily. They could use a pillow placed under the hips/pelvis sion of the prone position lasting longer than 1 hour; 4 re- if desired and rest in the lateral decubitus or supine position fol- fused the prone position and were intubated immediately. One lowed by repeat prone positioning. Do-not-resuscitate status did hour after initiation of the prone position, SpO increased com- not affect the decision to initiate or continue the use of the prone pared with baseline (Figure). The range of improvement in SpO position. The Columbia University institutional review board ap- was 1% to 34% (median [SE], 7% [1.2%]; 95% CI, 4.6%-9.4%). In all patients, the levels of supplemental oxygen were un- changed during the first hour of the prone position. One hour Figure. Oxyhemoglobin Saturation (SpO ) 1 Hour After Initiation of the Prone Position in Awake, Nonintubated Patients With COVID-19 after initiation of the prone position, 19 patients had SpO of 95% or greater; subsequently, 7 (37%) required intubation. Among 6 patients whose SpO remained less than 95% 1 hour after initiation of the prone position, 5 (83%) were intubated. The mean difference in the intubation rate among patients with SpO of 95% or greater vs SpO less than 95% 1 hour after ini- 2 2 tiation of the prone position was 46% (95% CI, 10%-88%). The Table shows other patient characteristics, none of which were associated with the need for intubation. Among 12 patients who required intubation, 3 died subsequently in the intensive care unit. Among 13 patients who did not require intubation, 9 re- covered and were discharged from the hospital, 2 were trans- ferred to the medical ward, and 2 remained in the step-down unit at the time data were censored on May 25, 2020. Start 1 h Awake proning Discussion | In this small single-center cohort study, we found SpO before and1hafter initiation of the prone position in awake, nonintubated that the use of the prone position for awake, spontaneously patients with COVID-19 severe hypoxemic respiratory failure (n = 25). breathing patients with COVID-19 severe hypoxemic respira- Table. Bivariate Analysis of Patient Characteristics and Their Association With Intubation After Use of the Prone Position in the 25 Awake, Nonintubated Patients With COVID-19 Intubation rate No. (%) difference, % Abbreviation: NA, not applicable. Characteristic Not intubated (n = 13) Intubated (n = 12) (95% CI) Age, median (range), y 67.0 (45.0 to 71.0) 66.0 (53.0 to 87.0) 4 (−35 to 43) For a binary risk factor x, the intubation risk difference is defined Sex (female) 3 (23) 4 (33) 7 (−36 to 50) by Δ=[intubation rate׀ x=yes]− Body mass index, median (range) 29.0 (21.0 to 47.0) 27.5 (22.0 to 33.0) −4 (−43 to 35) [intubation rate׀ x=no]. When x is a Hypertension 7 (54) 5 (42) 12 (−26 to 51) continuous risk factor, the intubation risk difference is defined Diabetes 5 (39) 5 (42) −3 (−43 to 36) by Δ = [intubation rate׀ Hyperlipidemia 1 (8) 2 (17) −21 (−78 to 36) x  median]−[intubation rate׀ Coronary artery disease 1 (8) 1 (8) −2 (−74 to 70) x < median]. The 95% CI of Δ is Chronic lung disease 2 (15) 2 (17) −2 (−74 to 70) constructed by Δ ± SE where SE is Δ Δ the standard error of Δ. None of the Chronic kidney disease 1 (8) 0 NA differences were significant. Symptom onset to prone position, median 12.0 (6.0 to 24.0) 12.0 (4.0 to 19.0) −20 (−59 to 19) (range), d Calculated as weight in kilograms divided by height in meters Days from admission to prone position, 3.0 (1.0 to 12.0) 3.5 (1.0 to 7.0) −20 (−59 to 19) median (range) squared. Duration of prone position on day 1, 4.0 (1.0 to 24.0) 6.0 (1.0 to 24.0) −35 (−72 to 0) Chronic lung disease includes median (range), h asthma, chronic obstructive Days for use of the prone position, median 2.0 (1.0 to 5.0) 2.0 (1.0 to 3.0) 26 (−13 to 67) pulmonary disease, and interstitial (range) lung disease. 1538 JAMA Internal Medicine November 2020 Volume 180, Number 11 (Reprinted) jamainternalmedicine.com SpO , % 2 Letters tory failure was associated with improved oxygenation. In ad- Invited Commentary dition, patients with an SpO of 95% or greater after 1 hour of Prone Positioning in Awake, Nonintubated Patients the prone position was associated with a lower rate of intuba- With COVID-19: Necessity Is the Mother of Invention tion. Limitations of our study are the lack of control group and In this issue of JAMA Internal Medicine, Thompson and col- a small sample size. Randomized clinical trials are needed to leagues report the association of prone positioning with pulse establish whether improved oxygenation after use of the prone oximetry in 25 awake, nonintubated patients with hypox- position in awake, nonintubated patients improves survival. emic respiratory failure due to coronavirus disease 2019 (COVID-19). This study in- Alison E. Thompson, MD cluded patients who were hy- Related article page 1537 Benjamin L. Ranard, MD poxemic (oxyhemoglobin Ying Wei, PhD saturation [SpO ] ≤ 93%) despite receiving 15 L/min oxygen by Sanja Jelic, MD face mask and 6 L/min oxygen by nasal cannula and excluded patients who were unable to turn in bed without assistance and Author Affiliations: Division of Pulmonary, Allergy, and Critical Care Medicine, those determined to be in respiratory distress and requiring ColumbiaUniversityVagelosCollegeofPhysiciansandSurgeons,NewYork,NewYork immediate intubation. The median (SE) improvement in oxy- (Thompson, Ranard, Jelic); Division of Biostatistics, Columbia University Vagelos gen saturation was 7% (1.2%) (95% CI, 4.6%-9.4%) after 1 hour College of Physicians and Surgeons, New York, New York (Wei). of prone positioning. This study adds to a growing body of lit- Accepted for Publication: May 29, 2020. erature suggesting that prone positioning may improve oxy- Published Online: June 17, 2020. doi:10.1001/jamainternmed.2020.3030 genation in patients with early acute respiratory distress syn- Open Access: This is an open access article distributed under the terms of the CC- BY License. © 2020 Thompson AE et al. JAMA Internal Medicine. drome (ARDS) prior to intubation. Prone positioning has several beneficial effects on pulmo- Corresponding Author: Sanja Jelic, MD, Division of Pulmonary, Allergy, and Critical Care Medicine, Columbia University Vagelos College of Physicians and nary physiology in patients with ARDS. In the supine posi- Surgeons, 630 W 168th St, PH8 Center, Room 101, New York, NY 10032 tion, pulmonary edema accumulates in basilar regions, and the (sj366@cumc.columbia.edu). heart and abdominal contents further compress these depen- Author Contributions: Dr Jelic had full access to all the data in the study and dent lung regions. This leads to heterogenous ventilation, with takes responsibility for the integrity of the data and the accuracy of the data analysis. Drs Thompson and Ranard served as co–first authors and contributed increased volume delivered to apical and anterior lung units, equally to the work. which are also the regions that receive less of the pulmonary Study concept and design: Thompson, Ranard, Jelic. circulation. Together, these factors lead to perfusion of poorly Acquisition, analysis, or interpretation of data: All authors. ventilated lung units and hypoxemia. Prone positioning of the Drafting of the manuscript: All authors. Critical revision of the manuscript for important intellectual content: All authors. patient leads to a more homogeneous distribution of ventila- Statistical analysis: Wei. tion, thus decreasing the shunt fraction and improving match- Obtained funding: Jelic. ing of ventilation and perfusion. Moreover, homogeneous ven- Administrative, technical, or material support: Thompson, Ranard, Jelic. tilation may decrease lung injury by more evenly distributing Study supervision: Thompson, Ranard, Jelic. mechanical force from the ventilator across the lung during Conflict of Interest Disclosures: None reported. inhalation. Funding/Support: This work was supported by National Institutes of Health/ National Heart, Lung, and Blood Institute (NIH/NHLBI) grants R01HL106041 Despite compelling experimental evidence of these physi- and R01HL137234 (Dr Jelic). ologic changes, most of the early randomized clinical trials of Role of the Funder/Sponsor: The NIH/NHLBI had no role in the design and the prone position in mechanically ventilated patients with conduct of the study; collection, management, analysis, and interpretation of ARDS did not demonstrate a benefit compared with standard the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. care. These trials, however, may have been limited by the late Additional Information: The study was registered on ClinicalTrials.gov on May initiation and short duration of the use of the prone position. 25, 2020, owing to the emergency nature of the treatment being administered To address these limitations, the Proning Severe ARDS Pa- based on clinical decision to critically ill patients with severe COVID-19 tients (PROSEVA) trial, published in 2013, randomized pa- hypoxemic respiratory failure. tients with a ratio of arterial oxygen tension (PaO ) to fraction 1. City of New York. COVID-19: data. Accessed April 17, 2020. https://www1.nyc. of inspired oxygen (FIO ) less than 150 mm Hg within 36 hours gov/site/doh/covid/covid-19-data.page 2 of intubation to be placed in the prone position for long dura- 2. Guérin C, Reignier J, Richard JC, et al; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013; tions—on average, 17 hours a day. The comparison group was 368(23):2159-2168. doi:10.1056/NEJMoa1214103 patients ventilated in the supine position. The trial found a haz- 3. Gattinoni L, Taccone P, Carlesso E, Marini JJ. Prone position in acute ard ratio for death of 0.39 (95% CI, 0.25-0.63) in the study arm respiratory distress syndrome. rationale, indications, and limits. Am J Respir Crit with prone positioning compared with standard care (mortal- Care Med. 2013;188(11):1286-1293. doi:10.1164/rccm.201308-1532CI ity at 28 days, 16.0% vs 32.8%). The findings have led to in- 4. Sun Q, Qiu H, Huang M, Yang Y. Lower mortality of COVID-19 by early creased adoption of prone positioning for mechanically ven- recognition and intervention: experience from Jiangsu Province. Ann Intensive Care. 2020;10(1):33. doi:10.1186/s13613-020-00650-2 tilated patients with moderate to severe ARDS. 5. Pérez-Nieto OR, Guerrero-Gutiérrez MA, Deloya-Tomas E, Ñamendys-Silva Before COVID-19, there was limited published research on SA. Prone positioning combined with high-flow nasal cannula in severe prone positioning in nonintubated patients. The COVID-19 noninfectious ARDS. Crit Care. 2020;24(1):114. doi:10.1186/s13054-020-2821-y pandemic, however, has led to a sudden and dramatic in- 6. DingL,WangL,MaW,HeH.Efficacyandsafetyofearlypronepositioningcombined crease in the number of patients requiring respiratory sup- withHFNCorNIVinmoderatetosevereARDS:amulti-centerprospectivecohortstudy. Crit Care. 2020;24(1):28. doi:10.1186/s13054-020-2738-5 port for ARDS, straining critical care resources at many hos- jamainternalmedicine.com (Reprinted) JAMA Internal Medicine November 2020 Volume 180, Number 11 1539 © 2020 American Medical Association. All rights reserved. Letters AuthorAffiliations: DivisionofPulmonary,CriticalCare,Allergy,andSleepMedicine, pitals and forcing clinicians to use innovative approaches to Department of Medicine, University of California, San Francisco (Sarma, Calfee); limit the need for mechanical ventilation, including so-called Department of Anesthesia, University of California, San Francisco (Calfee). awake proning. In a report on 50 nonintubated hypoxemic pa- Corresponding Author: Carolyn S. Calfee, MD, MAS, Department of tients with suspected COVID-19 who presented to an emer- Anesthesia, University of California, San Francisco, 505 Parnassus Ave, Box 0111, gency department in New York City, Caputo and colleagues San Francisco, CA 94143-0111 (carolyn.calfee@ucsf.edu). found a significant increase in SpO 5 minutes after proning 2 Published Online: June 17, 2020. doi:10.1001/jamainternmed.2020.3027 (preproning: 84%; interquartile range [IQR], 75%-85%; post- Conflict of Interest Disclosures: Dr Calfee reported grants from the National proning: 94%; IQR, 90%-95%; P = .001). Elharrar et al con- Institutes of Health during the submitted work, and grants from Roche/ Genentech and Bayer and personal fees from Quark, GEn1E Lifesciences, CSL ducted an observational study of prone positioning in pa- Behring, Prometic Life Sciences (now Liminal BioSciences), and Vasomune tients with confirmed COVID-19 and posterior lung opacities Therapeutics outside the submitted work. No other disclosures were reported. on chest computed tomography who were admitted to a single Funding/Support: The work was supported by grants from the National center in France, most of whom were on4Lor less of oxygen Institutes of Health (HL140026, Dr Calfee; HL151117, Dr Sarma). delivered via nasal cannula. Among 24 eligible patients, the Role of the Funder/Sponsor: The National Institutes of Health had no role in majority (15 [63%]) were able to tolerate being prone for at least the preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. 3 hours, but oxygenation increased with the prone position in 1. ThompsonAE,RanardBL,WeiY,JelicS.Pronepositioninginawake,nonintubated only 6 patients (25%). Finally, Sartini et al tested prone posi- patients with COVID-19 hypoxemic respiratory failure. JAMA Intern Med. Published tioning in 15 patients admitted to a single center in Milan, Italy, online June 17, 2020. doi:10.1001/jamainternmed.2020.3030 who were hypoxemic despite 10 cm H O continuous positive 2. Scholten EL, Beitler JR, Prisk GK, Malhotra A. Treatment of ARDS with prone airway pressure and 0.6 FIO , and SpO increased in all 15 pa- 2 2 positioning. Chest. 2017;151(1):215-224. doi:10.1016/j.chest.2016.06.032 tients. The report by Thompson et al adds to this body of ob- 3. Guérin C, Reignier J, Richard J-C, et al; PROSEVA Study Group. Prone servational evidence by demonstrating that many patients with positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013; 368(23):2159-2168. doi:10.1056/NEJMoa1214103 severe acute hypoxemic respiratory failure yet not on posi- 4. DingL,WangL,MaW,HeH.Efficacyandsafetyofearlypronepositioningcombined tive pressure ventilation had improved oxygenation in the 1 withHFNCorNIVinmoderatetosevereARDS:amulti-centerprospectivecohortstudy. prone position. Crit Care. 2020;24(1):28. doi:10.1186/s13054-020-2738-5 Although promising, these case series should be inter- 5. CaputoND,StrayerRJ,LevitanR.Earlyself-proninginawake,non-intubatedpatients preted with caution because of the lack of randomization. Even intheemergencydepartment:asingleED’sexperienceduringtheCOVID-19pandemic. in this selected group of patients, not all patients tolerated the Acad Emerg Med. 2020;27(5):375-378. doi:10.1111/acem.13994 prone position, and nearly half the patients in the case series 6. Elharrar X, Trigui Y, Dols A-M, et al. Use of prone positioning in nonintubated patients with COVID-19 and hypoxemic acute respiratory failure. JAMA.2020; from Thompson et al eventually required intubation. Al- 323(22):2336-2338. doi:10.1001/jama.2020.8255 though improved oxygen saturation with the prone position 7. Sartini C, Tresoldi M, Scarpellini P, et al. Respiratory parameters in patients with is important, hypoxemia has not been a reliable surrogate bio- COVID-19 after using noninvasive ventilation in the prone position outside the inten- marker for mortality in clinical trials of ARDS. Notably, in the sive care unit. JAMA. 2020;323(22):2338-2340. doi:10.1001/jama.2020.7861 National Heart, Lung, and Blood Institute ARDS Network trial 8. Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A; of low tidal volumes, the PaO /FIO ratio was higher in the Acute Respiratory Distress Syndrome Network. Ventilation with lower tidal 2 2 volumes as compared with traditional tidal volumes for acute lung injury and high-tidal-volume arm than the low-tidal-volume arm on the acute respiratory distress syndrome. N Engl J Med. 2000;342(18):1301-1308. study days 1 and 3. Nonetheless, mortality was lower in the doi:10.1056/NEJM200005043421801 low-tidal-volume arm (31.0% vs 39.8%). 9. Kangelaris KN, Ware LB, Wang CY, et al. Timing of intubation and clinical One potential concern with the use of the prone position outcomes in adults with acute respiratory distress syndrome. Crit Care Med. in spontaneously breathing patients is that it could delay 2016;44(1):120-129. doi:10.1097/CCM.0000000000001359 intubation and mechanical ventilation. The optimal timing of intubation and mechanical ventilation for patients with LESS IS MORE ARDS is not known, but delayed intubation has been associ- Potential Association of the ISCHEMIA Trial ated with increased mortality in patients with ARDS. Spon- With the Appropriate Use Criteria Ratings taneously breathing patients with ARDS generate relatively for Percutaneous Coronary Intervention large tidal volumes; the result could be inadvertent self- in Stable Ischemic Heart Disease inflicted lung injury. Controlled modes of mechanical venti- Decreasing the risk for major adverse cardiovascular events lation minimize progression of lung injury owing to baro- (eg, myocardial infarction and death) and alleviating symp- trauma. These benefits should be balanced with the risks of toms are primary therapeu- mechanical ventilation, including the need for prolonged tic goals of percutaneous Editor's Note page 1536 sedation and the risk of ventilator-associated pneumonia. coronary intervention (PCI) Ongoing clinical trials of prone positioning in non– in patients with stable ische- Author Audio Interview mechanically ventilated patients (eg, NCT04383613, mic heart disease (SIHD). NCT04359797) should help clarify the role of this simple, Current appropriate use cri- low-cost approach for patients with acute hypoxemic respi- Related article page 1534 teria (AUC) developed by ratory failure. national cardiovascular soci- eties classify PCIs as appropriate, maybe appropriate, or Aartik Sarma, MD rarely appropriate. Recently, the International Study of Carolyn S. Calfee, MD, MAS Comparative Health Effectiveness With Medical and Inva- 1540 JAMA Internal Medicine November 2020 Volume 180, Number 11 (Reprinted) jamainternalmedicine.com © 2020 American Medical Association. All rights reserved. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Internal Medicine American Medical Association

Prone Positioning in Awake, Nonintubated Patients With COVID-19 Hypoxemic Respiratory Failure

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Letters Conflict of Interest Disclosures: Dr Redberg receives research funding from as inappropriate for PCI (13% of all cases). Notably, this figure the Arnold Ventures Foundation, Greenwall Foundation, Flight Attendant likely greatly underestimates the number of inappropriate PCIs Medical Research Institute, and National Institutes of Health. No other because the authors were unable to determine if sympto- disclosures are reported. matic patients had first tried and failed optimal medical man- 1. Grady D, Redberg RF. Less is more: how less health care can result in better agement before undergoing PCI. health. Arch Intern Med. 2010;170(9):749-750. doi:10.1001/archinternmed. 2010.90 Although robust guidelines should be expected to reduce in- 2. Malik AO, Spertus JA, Patel MR, et al. Potential association of the ISCHEMIA appropriate PCI, Howard and Desai demonstrate how imple- trial with the appropriate use criteria ratings for percutaneous coronary menting such criteria depends on accurately reporting case char- intervention in stable ischemic heart disease. JAMA Intern Med. Published online acteristics (eg, the severity of coronary stenosis and symptoms) September 21, 2020. doi:10.1001/jamainternmed.2020.3181 and highlight egregious examples for which the reporting was 3. Howard DH, Desai NR. US False Claims Act investigations of unnecessary not only inaccurate but dishonest. Specifically, they investigated percutaneous coronary interventions. JAMA Intern Med. Published online September 21, 2020. doi:10.1001/jamainternmed.2020.2812 the association of the US False Claims Act, a law that allows 4. Stergiopoulos K, Boden WE, Hartigan P, et al. Percutaneous coronary whistleblowers to raise concerns of inappropriate care, with PCI 2 intervention outcomes in patients with stable obstructive coronary artery volumesforpatientswithoutacuteMI. Between2006and2016, disease and myocardial ischemia: a collaborative meta-analysis of the authors identified 8 cases of PCI-related US False Claims Act contemporary randomized clinical trials. JAMA Intern Med. 2014;174(2):232-240. cases that became public. Compared with matched control hos- doi:10.1001/jamainternmed.2013.12855 pitals, PCI volumes for nonacute MI decreased more from 2006 5. Maron DJ, Hochman JS, Reynolds HR, et al; ISCHEMIA Research Group. Initial invasive or conservative strategy for stable coronary disease. N Engl J Med. and 2016 in hospitals subject to claims of dishonest reporting 2020;382(15):1395-1407. doi:10.1056/NEJMoa1915922 (68.4% vs 81.2%; P< .001). Although the substantial decrease in 6. Holmboe ES, Fiellin DA, Cusanelli E, Remetz M, Krumholz HM. Perceptions of PCI seen in all hospitals suggests an overall movement to a more benefit and risk of patients undergoing first-time elective percutaneous evidence-based use of PCI, the differential decrease in hospitals coronary revascularization. J Gen Intern Med. 2000;15(9):632-637. doi:10.1046/ that underwent investigations of false claims suggests that there j.1525-1497.2000.90823.x is a role for the enforcement of accurate reporting of indications 7. Rothberg MB, Sivalingam SK, Ashraf J, et al. Patients’ and cardiologists’ perceptions of the benefits of percutaneous coronary intervention for stable for PCI. It is unknown how commonly coronary stenosis is over- coronary disease. Ann Intern Med. 2010;153(5):307-313. doi:10.7326/0003- estimated in centers that have not been targeted by False Claims 4819-153-5-201009070-00005 cases. Despite the effect of these efforts, without quantitative, 8. Lin GA, Dudley RA, Redberg RF. Cardiologists’ use of percutaneous coronary objective standards for stenosis, it is likely that some overesti- interventions for stable coronary artery disease. Arch Intern Med. 2007;167 mation of coronary stenosis will remain. (15):1604-1609. doi:10.1001/archinte.167.15.1604 Reports of continued substantial rates of inappropriate PCI 9. Weintraub WS, Spertus JA, Kolm P, et al; COURAGE Trial Research Group. Effect of PCI on quality of life in patients with stable coronary disease. N Engl J provide a compelling illustration of the considerable work that Med. 2008;359(7):677-687. doi:10.1056/NEJMoa072771 remains to protect patients and the health care system from 10. Zhang H, Mu L, Hu S, et al; China PEACE Collaborative Group. Comparison the harms and costs of unnecessary PCI. As a conservative es- of physician visual assessment with quantitative coronary angiography in timate (ie, not including cases that could be averted with op- assessment of stenosis severity in China. JAMA Intern Med. 2018;178(2):239-247. timal medical management or the costs of adverse outcomes doi:10.1001/jamainternmed.2017.7821 of PCIs), if the approximately 50 000 PCI cases deemed rarely 11. Bress AP, Bellows BK, King JB, et al; SPRINT Research Group. Cost-effectiveness of intensive versus standard blood-pressure control. N Engl J appropriate by Malik et al were averted at a cost of $30 000 Med. 2017;377(8):745-755. doi:10.1056/NEJMsa1616035 per PCI, this would produce a savings of $1.5 billion annu- 12. Borden WB, Redberg RF, Mushlin AI, Dai D, Kaltenbach LA, Spertus JA. ally. However, if we extrapolate from prior work showing that Patterns and intensity of medical therapy in patients undergoing percutaneous greater than 50% of patients undergoing PCIs with stable CAD coronary intervention. JAMA. 2011;305(18):1882-1889. doi:10.1001/jama.2011.601 are not receiving optimal medical therapy, it is likely that at least 150 000 more PCI cases are inappropriate and cost sav- ings are closer to $6 billion annually. The work of these au- Prone Positioning in Awake, Nonintubated Patients thors shows a promising method of reducing unnecessary PCI With COVID-19 Hypoxemic Respiratory Failure by combining robust, unambiguous consensus guidelines with Critically ill patients with coronavirus disease 2019 (COVID-19) enforcement of accurate reporting of indications for PCI. How- severely strained intensive care resources in New York City in ever, these measures are not a cure-all in a health care system April 2020. The prone position improves oxygenation in intu- 2,3 propelled by enthusiasm for technology regardless of net ben- bated patients with acute respiratory distress syndrome. efits and rewarded with fee-for-service payments not associ- We investigated whether the ated with the appropriateness of the procedure. prone position is associated Invited Commentary with improved oxygenation page 1539 James W. Salazar, MD, MAS and decreased risk for intuba- Rita F. Redberg, MD, MSc tion in spontaneously breathing patients with severe COVID-19 4-6 hypoxemic respiratory failure. Author Affiliations: Department of Medicine, University of California, San Francisco (Salazar, Redberg); Editor, JAMA Internal Medicine (Redberg). Methods | We screened consecutive patients admitted to the Co- Published Online: September 21, 2020. doi:10.1001/jamainternmed.2020.2801 lumbia University step-down unit (intermediate care unit) be- Corresponding Author: Rita F. Redberg, MD, MSc, Department of Medicine, tween April 6 and April 14, 2020 (N = 88). Inclusion criteria were University of California, San Francisco, 505 Parnassus, M1180, San Francisco, CA 94143-0124 (rita.redberg@ucsf.edu). laboratory-confirmed COVID-19 with severe hypoxemic respi- jamainternalmedicine.com (Reprinted) JAMA Internal Medicine November 2020 Volume 180, Number 11 1537 Letters ratory failure defined as respiratory rate of 30 breaths/min or proved the study and waived the need for informed consent from greater and oxyhemoglobin saturation (SpO ) of 93% or less while the participants, as we analyzed deidentified data collected from receiving supplemental oxygen 6 L/min via nasal cannula and electronic medical records. The primary outcome was change in 15 L/min via nonrebreather face mask. A confirmed case of SpO before and 1 hour after initiation of the prone position. We COVID-19 was defined by a positive result on a reverse report the median change in SpO with 95% CIs. We used the Wil- transcriptase–polymerase chain reaction assay of a specimen col- coxon test for analysis of change in SpO . We assessed the mean lected on a nasopharyngeal swab. Exclusion criteria were altered risk difference in intubation rates for patients with SpO of 95% mental status with inability to turn in bed without assistance or greater vs SpO less than 95% 1 hour after initiation of the prone (n = 13), extreme respiratory distress requiring immediate intu- position. We assessed intubation rates across demographic and bation (n = 23), or oxygen requirements less than those specified other clinical factors with RStudio, version 1.2.5019 (RStudio). in the inclusion criteria (n = 23). We asked eligible patients (n = 29) to lie on their stomach for as long as tolerated up to 24 Results | Among 29 eligible patients, 25 had at least 1 awake ses- hours daily. They could use a pillow placed under the hips/pelvis sion of the prone position lasting longer than 1 hour; 4 re- if desired and rest in the lateral decubitus or supine position fol- fused the prone position and were intubated immediately. One lowed by repeat prone positioning. Do-not-resuscitate status did hour after initiation of the prone position, SpO increased com- not affect the decision to initiate or continue the use of the prone pared with baseline (Figure). The range of improvement in SpO position. The Columbia University institutional review board ap- was 1% to 34% (median [SE], 7% [1.2%]; 95% CI, 4.6%-9.4%). In all patients, the levels of supplemental oxygen were un- changed during the first hour of the prone position. One hour Figure. Oxyhemoglobin Saturation (SpO ) 1 Hour After Initiation of the Prone Position in Awake, Nonintubated Patients With COVID-19 after initiation of the prone position, 19 patients had SpO of 95% or greater; subsequently, 7 (37%) required intubation. Among 6 patients whose SpO remained less than 95% 1 hour after initiation of the prone position, 5 (83%) were intubated. The mean difference in the intubation rate among patients with SpO of 95% or greater vs SpO less than 95% 1 hour after ini- 2 2 tiation of the prone position was 46% (95% CI, 10%-88%). The Table shows other patient characteristics, none of which were associated with the need for intubation. Among 12 patients who required intubation, 3 died subsequently in the intensive care unit. Among 13 patients who did not require intubation, 9 re- covered and were discharged from the hospital, 2 were trans- ferred to the medical ward, and 2 remained in the step-down unit at the time data were censored on May 25, 2020. Start 1 h Awake proning Discussion | In this small single-center cohort study, we found SpO before and1hafter initiation of the prone position in awake, nonintubated that the use of the prone position for awake, spontaneously patients with COVID-19 severe hypoxemic respiratory failure (n = 25). breathing patients with COVID-19 severe hypoxemic respira- Table. Bivariate Analysis of Patient Characteristics and Their Association With Intubation After Use of the Prone Position in the 25 Awake, Nonintubated Patients With COVID-19 Intubation rate No. (%) difference, % Abbreviation: NA, not applicable. Characteristic Not intubated (n = 13) Intubated (n = 12) (95% CI) Age, median (range), y 67.0 (45.0 to 71.0) 66.0 (53.0 to 87.0) 4 (−35 to 43) For a binary risk factor x, the intubation risk difference is defined Sex (female) 3 (23) 4 (33) 7 (−36 to 50) by Δ=[intubation rate׀ x=yes]− Body mass index, median (range) 29.0 (21.0 to 47.0) 27.5 (22.0 to 33.0) −4 (−43 to 35) [intubation rate׀ x=no]. When x is a Hypertension 7 (54) 5 (42) 12 (−26 to 51) continuous risk factor, the intubation risk difference is defined Diabetes 5 (39) 5 (42) −3 (−43 to 36) by Δ = [intubation rate׀ Hyperlipidemia 1 (8) 2 (17) −21 (−78 to 36) x  median]−[intubation rate׀ Coronary artery disease 1 (8) 1 (8) −2 (−74 to 70) x < median]. The 95% CI of Δ is Chronic lung disease 2 (15) 2 (17) −2 (−74 to 70) constructed by Δ ± SE where SE is Δ Δ the standard error of Δ. None of the Chronic kidney disease 1 (8) 0 NA differences were significant. Symptom onset to prone position, median 12.0 (6.0 to 24.0) 12.0 (4.0 to 19.0) −20 (−59 to 19) (range), d Calculated as weight in kilograms divided by height in meters Days from admission to prone position, 3.0 (1.0 to 12.0) 3.5 (1.0 to 7.0) −20 (−59 to 19) median (range) squared. Duration of prone position on day 1, 4.0 (1.0 to 24.0) 6.0 (1.0 to 24.0) −35 (−72 to 0) Chronic lung disease includes median (range), h asthma, chronic obstructive Days for use of the prone position, median 2.0 (1.0 to 5.0) 2.0 (1.0 to 3.0) 26 (−13 to 67) pulmonary disease, and interstitial (range) lung disease. 1538 JAMA Internal Medicine November 2020 Volume 180, Number 11 (Reprinted) jamainternalmedicine.com SpO , % 2 Letters tory failure was associated with improved oxygenation. In ad- Invited Commentary dition, patients with an SpO of 95% or greater after 1 hour of Prone Positioning in Awake, Nonintubated Patients the prone position was associated with a lower rate of intuba- With COVID-19: Necessity Is the Mother of Invention tion. Limitations of our study are the lack of control group and In this issue of JAMA Internal Medicine, Thompson and col- a small sample size. Randomized clinical trials are needed to leagues report the association of prone positioning with pulse establish whether improved oxygenation after use of the prone oximetry in 25 awake, nonintubated patients with hypox- position in awake, nonintubated patients improves survival. emic respiratory failure due to coronavirus disease 2019 (COVID-19). This study in- Alison E. Thompson, MD cluded patients who were hy- Related article page 1537 Benjamin L. Ranard, MD poxemic (oxyhemoglobin Ying Wei, PhD saturation [SpO ] ≤ 93%) despite receiving 15 L/min oxygen by Sanja Jelic, MD face mask and 6 L/min oxygen by nasal cannula and excluded patients who were unable to turn in bed without assistance and Author Affiliations: Division of Pulmonary, Allergy, and Critical Care Medicine, those determined to be in respiratory distress and requiring ColumbiaUniversityVagelosCollegeofPhysiciansandSurgeons,NewYork,NewYork immediate intubation. The median (SE) improvement in oxy- (Thompson, Ranard, Jelic); Division of Biostatistics, Columbia University Vagelos gen saturation was 7% (1.2%) (95% CI, 4.6%-9.4%) after 1 hour College of Physicians and Surgeons, New York, New York (Wei). of prone positioning. This study adds to a growing body of lit- Accepted for Publication: May 29, 2020. erature suggesting that prone positioning may improve oxy- Published Online: June 17, 2020. doi:10.1001/jamainternmed.2020.3030 genation in patients with early acute respiratory distress syn- Open Access: This is an open access article distributed under the terms of the CC- BY License. © 2020 Thompson AE et al. JAMA Internal Medicine. drome (ARDS) prior to intubation. Prone positioning has several beneficial effects on pulmo- Corresponding Author: Sanja Jelic, MD, Division of Pulmonary, Allergy, and Critical Care Medicine, Columbia University Vagelos College of Physicians and nary physiology in patients with ARDS. In the supine posi- Surgeons, 630 W 168th St, PH8 Center, Room 101, New York, NY 10032 tion, pulmonary edema accumulates in basilar regions, and the (sj366@cumc.columbia.edu). heart and abdominal contents further compress these depen- Author Contributions: Dr Jelic had full access to all the data in the study and dent lung regions. This leads to heterogenous ventilation, with takes responsibility for the integrity of the data and the accuracy of the data analysis. Drs Thompson and Ranard served as co–first authors and contributed increased volume delivered to apical and anterior lung units, equally to the work. which are also the regions that receive less of the pulmonary Study concept and design: Thompson, Ranard, Jelic. circulation. Together, these factors lead to perfusion of poorly Acquisition, analysis, or interpretation of data: All authors. ventilated lung units and hypoxemia. Prone positioning of the Drafting of the manuscript: All authors. Critical revision of the manuscript for important intellectual content: All authors. patient leads to a more homogeneous distribution of ventila- Statistical analysis: Wei. tion, thus decreasing the shunt fraction and improving match- Obtained funding: Jelic. ing of ventilation and perfusion. Moreover, homogeneous ven- Administrative, technical, or material support: Thompson, Ranard, Jelic. tilation may decrease lung injury by more evenly distributing Study supervision: Thompson, Ranard, Jelic. mechanical force from the ventilator across the lung during Conflict of Interest Disclosures: None reported. inhalation. Funding/Support: This work was supported by National Institutes of Health/ National Heart, Lung, and Blood Institute (NIH/NHLBI) grants R01HL106041 Despite compelling experimental evidence of these physi- and R01HL137234 (Dr Jelic). ologic changes, most of the early randomized clinical trials of Role of the Funder/Sponsor: The NIH/NHLBI had no role in the design and the prone position in mechanically ventilated patients with conduct of the study; collection, management, analysis, and interpretation of ARDS did not demonstrate a benefit compared with standard the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. care. These trials, however, may have been limited by the late Additional Information: The study was registered on ClinicalTrials.gov on May initiation and short duration of the use of the prone position. 25, 2020, owing to the emergency nature of the treatment being administered To address these limitations, the Proning Severe ARDS Pa- based on clinical decision to critically ill patients with severe COVID-19 tients (PROSEVA) trial, published in 2013, randomized pa- hypoxemic respiratory failure. tients with a ratio of arterial oxygen tension (PaO ) to fraction 1. City of New York. COVID-19: data. Accessed April 17, 2020. https://www1.nyc. of inspired oxygen (FIO ) less than 150 mm Hg within 36 hours gov/site/doh/covid/covid-19-data.page 2 of intubation to be placed in the prone position for long dura- 2. Guérin C, Reignier J, Richard JC, et al; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013; tions—on average, 17 hours a day. The comparison group was 368(23):2159-2168. doi:10.1056/NEJMoa1214103 patients ventilated in the supine position. The trial found a haz- 3. Gattinoni L, Taccone P, Carlesso E, Marini JJ. Prone position in acute ard ratio for death of 0.39 (95% CI, 0.25-0.63) in the study arm respiratory distress syndrome. rationale, indications, and limits. Am J Respir Crit with prone positioning compared with standard care (mortal- Care Med. 2013;188(11):1286-1293. doi:10.1164/rccm.201308-1532CI ity at 28 days, 16.0% vs 32.8%). The findings have led to in- 4. Sun Q, Qiu H, Huang M, Yang Y. Lower mortality of COVID-19 by early creased adoption of prone positioning for mechanically ven- recognition and intervention: experience from Jiangsu Province. Ann Intensive Care. 2020;10(1):33. doi:10.1186/s13613-020-00650-2 tilated patients with moderate to severe ARDS. 5. Pérez-Nieto OR, Guerrero-Gutiérrez MA, Deloya-Tomas E, Ñamendys-Silva Before COVID-19, there was limited published research on SA. Prone positioning combined with high-flow nasal cannula in severe prone positioning in nonintubated patients. The COVID-19 noninfectious ARDS. Crit Care. 2020;24(1):114. doi:10.1186/s13054-020-2821-y pandemic, however, has led to a sudden and dramatic in- 6. DingL,WangL,MaW,HeH.Efficacyandsafetyofearlypronepositioningcombined crease in the number of patients requiring respiratory sup- withHFNCorNIVinmoderatetosevereARDS:amulti-centerprospectivecohortstudy. Crit Care. 2020;24(1):28. doi:10.1186/s13054-020-2738-5 port for ARDS, straining critical care resources at many hos- jamainternalmedicine.com (Reprinted) JAMA Internal Medicine November 2020 Volume 180, Number 11 1539 © 2020 American Medical Association. All rights reserved. Letters AuthorAffiliations: DivisionofPulmonary,CriticalCare,Allergy,andSleepMedicine, pitals and forcing clinicians to use innovative approaches to Department of Medicine, University of California, San Francisco (Sarma, Calfee); limit the need for mechanical ventilation, including so-called Department of Anesthesia, University of California, San Francisco (Calfee). awake proning. In a report on 50 nonintubated hypoxemic pa- Corresponding Author: Carolyn S. Calfee, MD, MAS, Department of tients with suspected COVID-19 who presented to an emer- Anesthesia, University of California, San Francisco, 505 Parnassus Ave, Box 0111, gency department in New York City, Caputo and colleagues San Francisco, CA 94143-0111 (carolyn.calfee@ucsf.edu). found a significant increase in SpO 5 minutes after proning 2 Published Online: June 17, 2020. doi:10.1001/jamainternmed.2020.3027 (preproning: 84%; interquartile range [IQR], 75%-85%; post- Conflict of Interest Disclosures: Dr Calfee reported grants from the National proning: 94%; IQR, 90%-95%; P = .001). Elharrar et al con- Institutes of Health during the submitted work, and grants from Roche/ Genentech and Bayer and personal fees from Quark, GEn1E Lifesciences, CSL ducted an observational study of prone positioning in pa- Behring, Prometic Life Sciences (now Liminal BioSciences), and Vasomune tients with confirmed COVID-19 and posterior lung opacities Therapeutics outside the submitted work. No other disclosures were reported. on chest computed tomography who were admitted to a single Funding/Support: The work was supported by grants from the National center in France, most of whom were on4Lor less of oxygen Institutes of Health (HL140026, Dr Calfee; HL151117, Dr Sarma). delivered via nasal cannula. Among 24 eligible patients, the Role of the Funder/Sponsor: The National Institutes of Health had no role in majority (15 [63%]) were able to tolerate being prone for at least the preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. 3 hours, but oxygenation increased with the prone position in 1. ThompsonAE,RanardBL,WeiY,JelicS.Pronepositioninginawake,nonintubated only 6 patients (25%). Finally, Sartini et al tested prone posi- patients with COVID-19 hypoxemic respiratory failure. JAMA Intern Med. Published tioning in 15 patients admitted to a single center in Milan, Italy, online June 17, 2020. doi:10.1001/jamainternmed.2020.3030 who were hypoxemic despite 10 cm H O continuous positive 2. Scholten EL, Beitler JR, Prisk GK, Malhotra A. Treatment of ARDS with prone airway pressure and 0.6 FIO , and SpO increased in all 15 pa- 2 2 positioning. Chest. 2017;151(1):215-224. doi:10.1016/j.chest.2016.06.032 tients. The report by Thompson et al adds to this body of ob- 3. Guérin C, Reignier J, Richard J-C, et al; PROSEVA Study Group. Prone servational evidence by demonstrating that many patients with positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013; 368(23):2159-2168. doi:10.1056/NEJMoa1214103 severe acute hypoxemic respiratory failure yet not on posi- 4. DingL,WangL,MaW,HeH.Efficacyandsafetyofearlypronepositioningcombined tive pressure ventilation had improved oxygenation in the 1 withHFNCorNIVinmoderatetosevereARDS:amulti-centerprospectivecohortstudy. prone position. Crit Care. 2020;24(1):28. doi:10.1186/s13054-020-2738-5 Although promising, these case series should be inter- 5. CaputoND,StrayerRJ,LevitanR.Earlyself-proninginawake,non-intubatedpatients preted with caution because of the lack of randomization. Even intheemergencydepartment:asingleED’sexperienceduringtheCOVID-19pandemic. in this selected group of patients, not all patients tolerated the Acad Emerg Med. 2020;27(5):375-378. doi:10.1111/acem.13994 prone position, and nearly half the patients in the case series 6. Elharrar X, Trigui Y, Dols A-M, et al. Use of prone positioning in nonintubated patients with COVID-19 and hypoxemic acute respiratory failure. JAMA.2020; from Thompson et al eventually required intubation. Al- 323(22):2336-2338. doi:10.1001/jama.2020.8255 though improved oxygen saturation with the prone position 7. Sartini C, Tresoldi M, Scarpellini P, et al. Respiratory parameters in patients with is important, hypoxemia has not been a reliable surrogate bio- COVID-19 after using noninvasive ventilation in the prone position outside the inten- marker for mortality in clinical trials of ARDS. Notably, in the sive care unit. JAMA. 2020;323(22):2338-2340. doi:10.1001/jama.2020.7861 National Heart, Lung, and Blood Institute ARDS Network trial 8. Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A; of low tidal volumes, the PaO /FIO ratio was higher in the Acute Respiratory Distress Syndrome Network. Ventilation with lower tidal 2 2 volumes as compared with traditional tidal volumes for acute lung injury and high-tidal-volume arm than the low-tidal-volume arm on the acute respiratory distress syndrome. N Engl J Med. 2000;342(18):1301-1308. study days 1 and 3. Nonetheless, mortality was lower in the doi:10.1056/NEJM200005043421801 low-tidal-volume arm (31.0% vs 39.8%). 9. Kangelaris KN, Ware LB, Wang CY, et al. Timing of intubation and clinical One potential concern with the use of the prone position outcomes in adults with acute respiratory distress syndrome. Crit Care Med. in spontaneously breathing patients is that it could delay 2016;44(1):120-129. doi:10.1097/CCM.0000000000001359 intubation and mechanical ventilation. The optimal timing of intubation and mechanical ventilation for patients with LESS IS MORE ARDS is not known, but delayed intubation has been associ- Potential Association of the ISCHEMIA Trial ated with increased mortality in patients with ARDS. Spon- With the Appropriate Use Criteria Ratings taneously breathing patients with ARDS generate relatively for Percutaneous Coronary Intervention large tidal volumes; the result could be inadvertent self- in Stable Ischemic Heart Disease inflicted lung injury. Controlled modes of mechanical venti- Decreasing the risk for major adverse cardiovascular events lation minimize progression of lung injury owing to baro- (eg, myocardial infarction and death) and alleviating symp- trauma. These benefits should be balanced with the risks of toms are primary therapeu- mechanical ventilation, including the need for prolonged tic goals of percutaneous Editor's Note page 1536 sedation and the risk of ventilator-associated pneumonia. coronary intervention (PCI) Ongoing clinical trials of prone positioning in non– in patients with stable ische- Author Audio Interview mechanically ventilated patients (eg, NCT04383613, mic heart disease (SIHD). NCT04359797) should help clarify the role of this simple, Current appropriate use cri- low-cost approach for patients with acute hypoxemic respi- Related article page 1534 teria (AUC) developed by ratory failure. national cardiovascular soci- eties classify PCIs as appropriate, maybe appropriate, or Aartik Sarma, MD rarely appropriate. Recently, the International Study of Carolyn S. Calfee, MD, MAS Comparative Health Effectiveness With Medical and Inva- 1540 JAMA Internal Medicine November 2020 Volume 180, Number 11 (Reprinted) jamainternalmedicine.com © 2020 American Medical Association. All rights reserved.

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Published: Nov 17, 2020

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