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2.
Am J Case Rep ; 23: e937147, 2022 Oct 25.
Article in English | MEDLINE | ID: covidwho-2090898

ABSTRACT

BACKGROUND Inhaled nitric oxide (iNO) is used as a treatment for pulmonary arterial hypertension (PAH). Severe hypoxia with hypoxic vasoconstriction caused by severe acute respiratory distress syndrome (ARDS) can induce pulmonary hypertension with hemodynamic implications, mainly secondary to right ventricle (RV) systolic function impairment. We report the case of the use of iNO in a critically ill patient with bilateral SARS-CoV-2 pneumonia and severe ARDS and hypoxemia leading to acute severe PAH, causing a ventilation/perfusion mismatch, RV pressure overload, and RV systolic dysfunction. CASE REPORT A 36-year-old woman was admitted to the Intensive Care Unit with a severe ARDS associated with SARS-CoV-2 pneumonia requiring invasive mechanical ventilation. Severe hypoxia and hypoxic vasoconstriction developed, leading to an acute increase in pulmonary vascular resistance, severe to moderate tricuspid regurgitation, RV pressure overload, RV systolic function impairment, and RV dilatation. Following 24 h of treatment with iNO at 15 ppm, significant oxygenation and hemodynamic improvement were noted, allowing vasopressors to be stopped. After 24 h of iNO treatment, echocardiography showed very mild tricuspid regurgitation, a non-dilated RV, no impairment of transverse free wall contractility, and no paradoxical septal motion. iNO was maintained for 7 days. The dose of iNO was progressively decreased with no adverse effects and maintaining an improvement of oxygenation and hemodynamic status, allowing respiratory weaning. CONCLUSIONS Sustained acute hypoxia in ARDS secondary to SARS-CoV-2 pneumonia can lead to PAH, causing a ventilation/perfusion mismatch and RV systolic impairment. iNO can be considered in patients with significant PAH causing hypoxemia and RV dysfunction.


Subject(s)
COVID-19 , Hypertension, Pulmonary , Respiratory Distress Syndrome , Tricuspid Valve Insufficiency , Female , Humans , Adult , Nitric Oxide/therapeutic use , Hypertension, Pulmonary/drug therapy , Hypertension, Pulmonary/etiology , COVID-19/complications , Administration, Inhalation , SARS-CoV-2 , Respiratory Distress Syndrome/etiology , Respiratory Distress Syndrome/therapy , Hypoxia/etiology
3.
JAMA ; 328(11): 1063-1072, 2022 09 20.
Article in English | MEDLINE | ID: covidwho-2047353

ABSTRACT

Importance: Helmet noninvasive ventilation has been used in patients with COVID-19 with the premise that helmet interface is more effective than mask interface in delivering prolonged treatments with high positive airway pressure, but data about its effectiveness are limited. Objective: To evaluate whether helmet noninvasive ventilation compared with usual respiratory support reduces mortality in patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia. Design, Setting, and Participants: This was a multicenter, pragmatic, randomized clinical trial that was conducted in 8 sites in Saudi Arabia and Kuwait between February 8, 2021, and November 16, 2021. Adult patients with acute hypoxemic respiratory failure (n = 320) due to suspected or confirmed COVID-19 were included. The final follow-up date for the primary outcome was December 14, 2021. Interventions: Patients were randomized to receive helmet noninvasive ventilation (n = 159) or usual respiratory support (n = 161), which included mask noninvasive ventilation, high-flow nasal oxygen, and standard oxygen. Main Outcomes and Measures: The primary outcome was 28-day all-cause mortality. There were 12 prespecified secondary outcomes, including endotracheal intubation, barotrauma, skin pressure injury, and serious adverse events. Results: Among 322 patients who were randomized, 320 were included in the primary analysis, all of whom completed the trial. Median age was 58 years, and 187 were men (58.4%). Within 28 days, 43 of 159 patients (27.0%) died in the helmet noninvasive ventilation group compared with 42 of 161 (26.1%) in the usual respiratory support group (risk difference, 1.0% [95% CI, -8.7% to 10.6%]; relative risk, 1.04 [95% CI, 0.72-1.49]; P = .85). Within 28 days, 75 of 159 patients (47.2%) required endotracheal intubation in the helmet noninvasive ventilation group compared with 81 of 161 (50.3%) in the usual respiratory support group (risk difference, -3.1% [95% CI, -14.1% to 7.8%]; relative risk, 0.94 [95% CI, 0.75-1.17]). There were no significant differences between the 2 groups in any of the prespecified secondary end points. Barotrauma occurred in 30 of 159 patients (18.9%) in the helmet noninvasive ventilation group and 25 of 161 (15.5%) in the usual respiratory support group. Skin pressure injury occurred in 5 of 159 patients (3.1%) in the helmet noninvasive ventilation group and 10 of 161 (6.2%) in the usual respiratory support group. There were 2 serious adverse events in the helmet noninvasive ventilation group and 1 in the usual respiratory support group. Conclusions and Relevance: Results of this study suggest that helmet noninvasive ventilation did not significantly reduce 28-day mortality compared with usual respiratory support among patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia. However, interpretation of the findings is limited by imprecision in the effect estimate, which does not exclude potentially clinically important benefit or harm. Trial Registration: ClinicalTrials.gov Identifier: NCT04477668.


Subject(s)
COVID-19 , Noninvasive Ventilation , Oxygen Inhalation Therapy , Respiratory Insufficiency , Acute Disease , Barotrauma/etiology , COVID-19/complications , COVID-19/mortality , COVID-19/therapy , Female , Humans , Hypoxia/etiology , Hypoxia/mortality , Hypoxia/therapy , Male , Middle Aged , Noninvasive Ventilation/adverse effects , Noninvasive Ventilation/methods , Oxygen/administration & dosage , Oxygen/adverse effects , Oxygen Inhalation Therapy/adverse effects , Oxygen Inhalation Therapy/methods , Respiratory Insufficiency/etiology , Respiratory Insufficiency/mortality , Respiratory Insufficiency/therapy
4.
BMC Pediatr ; 22(1): 138, 2022 03 16.
Article in English | MEDLINE | ID: covidwho-2038685

ABSTRACT

BACKGROUND: To assess the outcome of extracorporeal membrane oxygenation (ECMO) for severe adenovirus (Adv) pneumonia with refractory hypoxic respiratory failure (RHRF) in paediatric patients. METHODS: A retrospective observational study was performed in a tertiary paediatric intensive care unit (PICU) in China. Patients with RHRF caused by Adv pneumonia who received ECMO support after mechanical ventilation failed to achieve adequate oxygenation between 2017 and 2020 were included. The outcome variables were the in-hospital survival rate and the effects of ECMO on the survival rate. RESULTS: In total, 18 children with RHRF received ECMO. The median age was 19 (9.5, 39.8) months, and the median ECMO duration was 196 (152, 309) h. The in-hospital survival rate was 72.2% (13/18). Thirteen patients (72.2%) required continuous renal replacement therapy (CRRT) due to fluid imbalance or acute kidney injury (AKI). At ECMO initiation, compared with survivors, nonsurvivors had a lower PaO2/FiO2 ratio [49 (34.5, 62) vs. 63 (56, 71); p = 0.04], higher oxygen index (OI) [41 (34.5, 62) vs. 30 (26.5, 35); p = 0.03], higher vasoactive inotropic score (VIS) [30 (16.3, 80) vs. 100 (60, 142.5); p = 0.04], longer duration from mechanical ventilation to ECMO support [8 (4, 14) vs. 4 (3, 5.5) h, p=0.02], and longer time from confirmed RHRF to ECMO initiation [9 (4.8, 13) vs. 5 (1.3, 5.5) h; p = 0.004]. Patients with PaO2/FiO2 <61 mmHg or an OI >43 and hypoxic respiratory failure for more than 9 days before the initiation of ECMO had worse outcomes. CONCLUSIONS: ECMO seemed to be effective, as severe paediatric Adv pneumonia patients with RHRF had a cumulative survival rate of 72.2% in our study. Our study provides insight into ECMO rescue in children with severe Adv pneumonia.


Subject(s)
Adenoviridae Infections , Extracorporeal Membrane Oxygenation , Pneumonia, Viral , Respiratory Insufficiency , Adenoviridae , Adult , Child , China , Humans , Hypoxia/etiology , Hypoxia/therapy , Oxygen , Pneumonia, Viral/complications , Pneumonia, Viral/therapy , Respiratory Insufficiency/etiology , Respiratory Insufficiency/therapy , Retrospective Studies , Treatment Outcome , Young Adult
6.
Undersea Hyperb Med ; 49(3): 295-305, 2022.
Article in English | MEDLINE | ID: covidwho-1998882

ABSTRACT

Introduction: Few treatments have demonstrated mortality benefits among hospitalized hypoxic COVID-19 patients. We evaluated the use of hyperbaric oxygen (HBO2) therapy as a therapeutic intervention among hospitalized patients with a high oxygen requirement prior to vaccine approval. Methods: We extracted data on patients with COVID-19 hypoxia who required oxygen supplementation ranging from a 6L nasal cannula up to a high-flow nasal cannula at 100% FiO2 at 60L/minute with a 100% non-rebreather mask at 15 L/minute and were eligible for off-label HBO2 therapy from October 2020 to February 2021. We followed the Monitored Emergency use of Unregistered and Investigational Interventions or (MEURI) in conjunction with the consistent re-evaluation of the protocol using the Plan-Do-Study-Act (PDSA) tool [1]. We compared patient characteristics and used Fisher's exact test and a survival analysis to assess the primary endpoint of inpatient death. Results: HBO2 therapy was offered to 36 patients, of which 24 received treatment and 12 did not receive treatment. Patients who did not receive treatment were significantly older (p ≺ 0.01) and had worse baseline hypoxia (p = 0.06). Three of the 24 (13%) patients who received treatment died compared to six of 12 (50%) patients who did not receive treatment (RR ratio: 0.25, p = 0.04, 95% CI: 0.08 to 0.83). In the survival analysis, there was a statistically significant reduction in inpatient mortality in the treatment group (HR: 0.19, p = 0.02, 95% CI: 0.05-0.74). However, after adjusting for age and baseline hypoxia, there was no difference in inpatient mortality (hazard ratio: 0.48, p = 0.42, 95% CI: 0.08-2.86). Conclusion: The survival benefit of HBO2 therapy observed in our unadjusted analysis suggests that there may be therapeutic benefits of HBO2 in treating COVID-19 hypoxia as an adjunct to standard care.


Subject(s)
COVID-19 , Hyperbaric Oxygenation , Vaccines , COVID-19/therapy , Humans , Hyperbaric Oxygenation/methods , Hypoxia/etiology , Hypoxia/therapy , Oxygen/therapeutic use , Treatment Outcome
7.
N Engl J Med ; 387(7): 599-610, 2022 08 18.
Article in English | MEDLINE | ID: covidwho-1991731

ABSTRACT

BACKGROUND: Early treatment to prevent severe coronavirus disease 2019 (Covid-19) is an important component of the comprehensive response to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. METHODS: In this phase 3, double-blind, randomized, placebo-controlled trial, we used a 2-by-3 factorial design to test the effectiveness of three repurposed drugs - metformin, ivermectin, and fluvoxamine - in preventing serious SARS-CoV-2 infection in nonhospitalized adults who had been enrolled within 3 days after a confirmed diagnosis of infection and less than 7 days after the onset of symptoms. The patients were between the ages of 30 and 85 years, and all had either overweight or obesity. The primary composite end point was hypoxemia (≤93% oxygen saturation on home oximetry), emergency department visit, hospitalization, or death. All analyses used controls who had undergone concurrent randomization and were adjusted for SARS-CoV-2 vaccination and receipt of other trial medications. RESULTS: A total of 1431 patients underwent randomization; of these patients, 1323 were included in the primary analysis. The median age of the patients was 46 years; 56% were female (6% of whom were pregnant), and 52% had been vaccinated. The adjusted odds ratio for a primary event was 0.84 (95% confidence interval [CI], 0.66 to 1.09; P = 0.19) with metformin, 1.05 (95% CI, 0.76 to 1.45; P = 0.78) with ivermectin, and 0.94 (95% CI, 0.66 to 1.36; P = 0.75) with fluvoxamine. In prespecified secondary analyses, the adjusted odds ratio for emergency department visit, hospitalization, or death was 0.58 (95% CI, 0.35 to 0.94) with metformin, 1.39 (95% CI, 0.72 to 2.69) with ivermectin, and 1.17 (95% CI, 0.57 to 2.40) with fluvoxamine. The adjusted odds ratio for hospitalization or death was 0.47 (95% CI, 0.20 to 1.11) with metformin, 0.73 (95% CI, 0.19 to 2.77) with ivermectin, and 1.11 (95% CI, 0.33 to 3.76) with fluvoxamine. CONCLUSIONS: None of the three medications that were evaluated prevented the occurrence of hypoxemia, an emergency department visit, hospitalization, or death associated with Covid-19. (Funded by the Parsemus Foundation and others; COVID-OUT ClinicalTrials.gov number, NCT04510194.).


Subject(s)
COVID-19 , Fluvoxamine , Ivermectin , Metformin , Adult , Aged , Aged, 80 and over , COVID-19/complications , COVID-19/drug therapy , COVID-19 Vaccines , Double-Blind Method , Female , Fluvoxamine/therapeutic use , Humans , Hypoxia/etiology , Ivermectin/therapeutic use , Male , Metformin/therapeutic use , Middle Aged , Obesity/complications , Overweight/complications , Pregnancy , Pregnancy Complications, Infectious/drug therapy , SARS-CoV-2
10.
Turk J Pediatr ; 64(3): 500-509, 2022.
Article in English | MEDLINE | ID: covidwho-1964985

ABSTRACT

BACKGROUND: Human coronaviruses (HCoVs) cause a comprehensive clinic ranging from asymptomatic course to pneumonia. We aimed to describe the HCoV infections in children to determine the clinical status and coinfection effects in a five-year retrospective surveillance study. The primary outcome was admission to the intensive care unit (ICU) and the secondary outcome was the need of high oxygen support. METHODS: Between September 2015 and November 2020, all patients whose reverse transcription polymerase chain reaction (RT-PCR) tests were positive were determined and patients with HCoVs were included in the study. Demographical characteristics, underlying chronic diseases, clinical diagnosis, laboratory data, subtypes of HCoVs, radiological findings, treatments, hospitalization, and ICU admission were analyzed. RESULTS: Of the 2606 children, the overall respiratory tract virus detection rate was 82.4%. Among these, 98 cases were HCoVs positive and of these 80 (81.6%) were under five years of age and most of the patients were admitted to the hospital in spring and 70% were a mixed infection with other respiratory viruses. Since lower respiratory tract infections are more common in HCoV coinfections, a significant difference was found in clinical diagnosis (p < 0.001). The presence of hypoxia (p=0.003) and underlying disease (p=0.004) were found to be significantly more common in patients admitted to the ICU. The presence of hypoxia, infiltration on chest X-ray, and elevated C-reactive protein levels were more frequently determined in patients who received high oxygen support (p=0.001, p=0.036, p=0.004, respectively). CONCLUSIONS: Clinical findings may be more severe if HCoVs, which generally cause mild respiratory disease, are coinfected with another viral agent.


Subject(s)
Coronavirus Infections , Coronavirus , Respiratory Tract Infections , Child , Coronavirus Infections/diagnosis , Coronavirus Infections/epidemiology , Coronavirus Infections/therapy , Humans , Hypoxia/etiology , Infant , Oxygen , Respiratory Tract Infections/epidemiology , Retrospective Studies , Seasons
11.
Bull World Health Organ ; 100(5): 302-314B, 2022 May 01.
Article in English | MEDLINE | ID: covidwho-1938580

ABSTRACT

Objective: To investigate survival in children referred from primary care in Malawi, with a focus on hypoglycaemia and hypoxaemia progression. Methods: The study involved a prospective cohort of children aged 12 years or under referred from primary health-care facilities in Mchinji district, Malawi in 2019 and 2020. Peripheral blood oxygen saturation (SpO2) and blood glucose were measured at recruitment and on arrival at a subsequent health-care facility (i.e. four hospitals and 14 primary health-care facilities). Children were followed up 2 weeks after discharge or their last clinical visit. The primary study outcome was the case fatality ratio at 2 weeks. Associations between SpO2 and blood glucose levels and death were evaluated using Cox proportional hazards models and the treatment effect of hospitalization was assessed using propensity score matching. Findings: Of 826 children recruited, 784 (94.9%) completed follow-up. At presentation, hypoxaemia was moderate (SpO2: 90-93%) in 13.1% (108/826) and severe (SpO2: < 90%) in 8.6% (71/826) and hypoglycaemia was moderate (blood glucose: 2.5-4.0 mmol/L) in 9.0% (74/826) and severe (blood glucose: < 2.5 mmol/L) in 2.3% (19/826). The case fatality ratio was 3.7% (29/784) overall but 26.3% (5/19) in severely hypoglycaemic children and 12.7% (9/71) in severely hypoxaemic children. Neither moderate hypoglycaemia nor moderate hypoxaemia was associated with mortality. Conclusion: Presumptive pre-referral glucose treatment and better management of hypoglycaemia could reduce the high case fatality ratio observed in children with severe hypoglycaemia. The morbidity and mortality burden of severe hypoxaemia was high; ways of improving hypoxaemia identification and management are needed.


Subject(s)
Blood Glucose , Hypoglycemia , Child , Cohort Studies , Humans , Hypoxia/etiology , Hypoxia/therapy , Prospective Studies , Referral and Consultation
14.
Respir Care ; 67(9): 1177-1189, 2022 09.
Article in English | MEDLINE | ID: covidwho-1924460

ABSTRACT

BACKGROUND: High-flow nasal cannula (HFNC) oxygen and noninvasive ventilation (NIV) have been widely used in patients with acute hypoxic respiratory failure (AHRF) due to COVID-19. However, the impact of HFNC versus NIV on clinical outcomes of COVID-19 is uncertain. Therefore, we performed this meta-analysis to evaluate the effect of HFNC versus NIV in COVID-19-related AHRF. METHODS: Several electronic databases were searched through February 10, 2022, for eligible studies comparing HFNC and NIV in COVID-19-related AHRF. Our primary outcome was intubation. The secondary outcomes were mortality, hospital length of stay (LOS), and PaO2 /FIO2 changes. Pooled risk ratio (RR) and mean difference (MD) with the corresponding 95% CI were obtained using a random-effect model. Prediction intervals were calculated to indicate the variance in outcomes that would be expected if new studies were conducted in the future. RESULTS: Nineteen studies involving 3,606 subjects (1,880 received HFNC and 1,726 received NIV) were included. There were no differences in intubation (RR 1.01 [95% CI 0.85-1.20], P = .89) or LOS (MD 0.38 d [95% CI -0.61 to 1.37], P = .45) between groups, with consistent results on the subgroup of randomized controlled trials (RCTs). Mortality was lower in NIV (RR 0.81 [95% CI 0.66-0.98], P = .03). However, the prediction interval was 0.41-1.59, and subgroup analysis of RCTs showed no difference in mortality between groups. There was a greater improvement in PaO2 /FIO2 with NIV (MD 22.80 [95% CI 5.30-40.31], P = .01). CONCLUSIONS: Our study showed that despite the greater improvement in PaO2 /FIO2 with NIV, intubation rates and LOS were similar between HFNC and NIV. Although mortality was lower with HFNC than NIV, the prediction interval included the null value, and there was no difference in mortality between HFNC and NIV on a subgroup of RCTs. Future large-scale RCTs are necessary to support our findings.


Subject(s)
COVID-19 , Noninvasive Ventilation , Respiratory Distress Syndrome , Respiratory Insufficiency , COVID-19/therapy , Cannula , Humans , Hypoxia/etiology , Hypoxia/therapy , Noninvasive Ventilation/methods , Oxygen Inhalation Therapy , Respiratory Insufficiency/etiology , Respiratory Insufficiency/therapy
15.
Trop Doct ; 52(4): 593-595, 2022 Oct.
Article in English | MEDLINE | ID: covidwho-1916713

ABSTRACT

Hypoxaemia in COVID-19 does not necessarily imply COVID pneumonia or post-COVID lung fibrosis, and the caveats of finger pulse oximetry should be remembered. Drug-induced methaemoglobinemia should be considered in individuals with unexplained cyanosis, refractory hypoxaemia, or the presence of a saturation gap. Here, we share our recent encounter of 'spurious hypoxia' in a patient with COVID-19 and methaemoglobinemia.


Subject(s)
COVID-19 , Pneumonia , COVID-19/complications , Humans , Hypoxia/diagnosis , Hypoxia/etiology , Oximetry , SARS-CoV-2
16.
Respir Care ; 67(10): 1343-1360, 2022 10.
Article in English | MEDLINE | ID: covidwho-1911886

ABSTRACT

Infection with SARS-CoV-2 in select individuals results in viral sepsis, pneumonia, and hypoxemic respiratory failure, collectively known as COVID-19. In the early months of the pandemic, the combination of novel disease presentation, enormous surges of critically ill patients, and severity of illness lent to early observations and pronouncements regarding COVID-19 that could not be scientifically validated owing to crisis circumstances. One of these was a phenomenon referred to as "happy hypoxia." Widely discussed in the lay press, it was thought to represent a novel and perplexing phenomenon: severe hypoxemia coupled with the absence of respiratory distress and dyspnea. Silent hypoxemia is the preferred term describing an apparent lack of distress in the presence of hypoxemia. However, the phenomenon is well known among respiratory physiologists as hypoxic ventilatory decline. Silent hypoxemia can be explained by physiologic mechanisms governing the control of breathing, breathing perception, and cardiovascular compensation. This narrative review examines silent hypoxemia during COVID-19 as well as hypotheses that viral infection of the central and peripheral nervous system may be implicated. Moreover, the credulous embrace of happy hypoxia and the novel hypotheses proposed to explain it has exposed significant misunderstandings among clinicians regarding the physiologic mechanisms governing both the control of breathing and the modulation of breathing sensations. Therefore, a substantial focus of this paper is to provide an in-depth review of these topics.


Subject(s)
COVID-19 , COVID-19/complications , Dyspnea/etiology , Humans , Hypoxia/epidemiology , Hypoxia/etiology , Pandemics , SARS-CoV-2
17.
Eur Respir Rev ; 31(164)2022 06 30.
Article in English | MEDLINE | ID: covidwho-1910263
18.
Med Intensiva (Engl Ed) ; 46(7): 410-412, 2022 07.
Article in English | MEDLINE | ID: covidwho-1907580
19.
Am J Case Rep ; 23: e936651, 2022 Jun 22.
Article in English | MEDLINE | ID: covidwho-1903899

ABSTRACT

BACKGROUND COVID-19 continues to place a tremendous burden on the healthcare system, with most deaths resulting from respiratory failure. Management strategies have varied, but the mortality rate for mechanically ventilated patients remains high. Conventional management with ARDSnet ventilation can improve outcomes but alternative and adjunct treatments continue to be explored. High-frequency oscillatory ventilation (HFOV), a modality now rarely used in adult critical care medicine, may offer an alternative treatment option by maximizing lung protection and limiting oxygen toxicity in critically ill patients failing conventional ventilator strategies. CASE REPORT We present 3 patients with severe acute respiratory distress syndrome (ARDS) and sepsis due to COVID-19 who all improved clinically after transitioning from conventional ventilation to HFOV. Two patients developed refractory hypoxemia with hemodynamic instability and multiple organ failure requiring vasopressor support and renal replacement therapy. After failing to improve with all available therapies, both patients stabilized and ultimately improved after being placed on HFOV. The third patient developed severe volutrauma/barotrauma despite extreme lung protection and ARDSnet ventilation. He showed improvement in oxygenation and signs of lung trauma slowly improved after initiating HFOV. All 3 patients were ultimately liberated from mechanical ventilation and discharged from the hospital to return to functional independence. CONCLUSIONS Our experience suggests that HFOV offers advantages in the management of certain critically ill patients with ARDS due to COVID-19 pneumonia and might be considered in cases refractory to standard management strategies.


Subject(s)
COVID-19 , High-Frequency Ventilation , Respiratory Distress Syndrome , Adult , COVID-19/complications , COVID-19/therapy , Critical Illness , High-Frequency Ventilation/adverse effects , High-Frequency Ventilation/methods , Humans , Hypoxia/etiology , Hypoxia/therapy , Male , Respiratory Distress Syndrome/etiology , Respiratory Distress Syndrome/therapy
20.
JAMA ; 327(21): 2104-2113, 2022 06 07.
Article in English | MEDLINE | ID: covidwho-1898487

ABSTRACT

Importance: The efficacy and safety of prone positioning is unclear in nonintubated patients with acute hypoxemia and COVID-19. Objective: To evaluate the efficacy and adverse events of prone positioning in nonintubated adult patients with acute hypoxemia and COVID-19. Design, Setting, and Participants: Pragmatic, unblinded randomized clinical trial conducted at 21 hospitals in Canada, Kuwait, Saudi Arabia, and the US. Eligible adult patients with COVID-19 were not intubated and required oxygen (≥40%) or noninvasive ventilation. A total of 400 patients were enrolled between May 19, 2020, and May 18, 2021, and final follow-up was completed in July 2021. Intervention: Patients were randomized to awake prone positioning (n = 205) or usual care without prone positioning (control; n = 195). Main Outcomes and Measures: The primary outcome was endotracheal intubation within 30 days of randomization. The secondary outcomes included mortality at 60 days, days free from invasive mechanical ventilation or noninvasive ventilation at 30 days, days free from the intensive care unit or hospital at 60 days, adverse events, and serious adverse events. Results: Among the 400 patients who were randomized (mean age, 57.6 years [SD, 12.83 years]; 117 [29.3%] were women), all (100%) completed the trial. In the first 4 days after randomization, the median duration of prone positioning was 4.8 h/d (IQR, 1.8 to 8.0 h/d) in the awake prone positioning group vs 0 h/d (IQR, 0 to 0 h/d) in the control group. By day 30, 70 of 205 patients (34.1%) in the prone positioning group were intubated vs 79 of 195 patients (40.5%) in the control group (hazard ratio, 0.81 [95% CI, 0.59 to 1.12], P = .20; absolute difference, -6.37% [95% CI, -15.83% to 3.10%]). Prone positioning did not significantly reduce mortality at 60 days (hazard ratio, 0.93 [95% CI, 0.62 to 1.40], P = .54; absolute difference, -1.15% [95% CI, -9.40% to 7.10%]) and had no significant effect on days free from invasive mechanical ventilation or noninvasive ventilation at 30 days or on days free from the intensive care unit or hospital at 60 days. There were no serious adverse events in either group. In the awake prone positioning group, 21 patients (10%) experienced adverse events and the most frequently reported were musculoskeletal pain or discomfort from prone positioning (13 of 205 patients [6.34%]) and desaturation (2 of 205 patients [0.98%]). There were no reported adverse events in the control group. Conclusions and Relevance: In patients with acute hypoxemic respiratory failure from COVID-19, prone positioning, compared with usual care without prone positioning, did not significantly reduce endotracheal intubation at 30 days. However, the effect size for the primary study outcome was imprecise and does not exclude a clinically important benefit. Trial Registration: ClinicalTrials.gov Identifier: NCT04350723.


Subject(s)
COVID-19 , Intubation, Intratracheal , Prone Position , Respiratory Insufficiency , Wakefulness , Adult , Aged , COVID-19/complications , COVID-19/therapy , Female , Humans , Hypoxia/etiology , Hypoxia/therapy , Intubation, Intratracheal/methods , Male , Middle Aged , Respiration, Artificial/methods , Respiratory Distress Syndrome/etiology , Respiratory Distress Syndrome/therapy , Respiratory Insufficiency/etiology , Respiratory Insufficiency/therapy
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