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1.
Crit Care ; 26(1): 16, 2022 01 07.
Article in English | MEDLINE | ID: covidwho-1613247

ABSTRACT

BACKGROUND: In patients with COVID-19-related acute respiratory failure (ARF), awake prone positioning (AW-PP) reduces the need for intubation in patients treated with high-flow nasal oxygen (HFNO). However, the effects of different exposure times on clinical outcomes remain unclear. We evaluated the effect of AW-PP on the risk of endotracheal intubation and in-hospital mortality in patients with COVID-19-related ARF treated with HFNO and analyzed the effects of different exposure times to AW-PP. METHODS: This multicenter prospective cohort study in six ICUs of 6 centers in Argentine consecutively included patients > 18 years of age with confirmed COVID-19-related ARF requiring HFNO from June 2020 to January 2021. In the primary analysis, the main exposure was awake prone positioning for at least 6 h/day, compared to non-prone positioning (NON-PP). In the sensitivity analysis, exposure was based on the number of hours receiving AW-PP. Inverse probability weighting-propensity score (IPW-PS) was used to adjust the conditional probability of treatment assignment. The primary outcome was endotracheal intubation (ETI); and the secondary outcome was hospital mortality. RESULTS: During the study period, 580 patients were screened and 335 were included; 187 (56%) tolerated AW-PP for [median (p25-75)] 12 (9-16) h/day and 148 (44%) served as controls. The IPW-propensity analysis showed standardized differences < 0.1 in all the variables assessed. After adjusting for other confounders, the OR (95% CI) for ETI in the AW-PP group was 0.36 (0.2-0.7), with a progressive reduction in OR as the exposure to AW-PP increased. The adjusted OR (95% CI) for hospital mortality in the AW-PP group ≥ 6 h/day was 0.47 (0.19-1.31). The exposure to prone positioning ≥ 8 h/d resulted in a further reduction in OR [0.37 (0.17-0.8)]. CONCLUSION: In the study population, AW-PP for ≥ 6 h/day reduced the risk of endotracheal intubation, and exposure ≥ 8 h/d reduced the risk of hospital mortality.


Subject(s)
COVID-19 , Oxygen Inhalation Therapy , Respiratory Insufficiency , Administration, Intranasal , COVID-19/complications , Humans , Oxygen/administration & dosage , Oxygen Inhalation Therapy/methods , Prone Position , Prospective Studies , Respiratory Insufficiency/therapy , Respiratory Insufficiency/virology , Time Factors , Treatment Outcome , Wakefulness
2.
Can J Anaesth ; 67(9): 1217-1248, 2020 09.
Article in English | MEDLINE | ID: covidwho-1536371

ABSTRACT

PURPOSE: We conducted two World Health Organization-commissioned reviews to inform use of high-flow nasal cannula (HFNC) in patients with coronavirus disease (COVID-19). We synthesized the evidence regarding efficacy and safety (review 1), as well as risks of droplet dispersion, aerosol generation, and associated transmission (review 2) of viral products. SOURCE: Literature searches were performed in Ovid MEDLINE, Embase, Web of Science, Chinese databases, and medRxiv. Review 1: we synthesized results from randomized-controlled trials (RCTs) comparing HFNC to conventional oxygen therapy (COT) in critically ill patients with acute hypoxemic respiratory failure. Review 2: we narratively summarized findings from studies evaluating droplet dispersion, aerosol generation, or infection transmission associated with HFNC. For both reviews, paired reviewers independently conducted screening, data extraction, and risk of bias assessment. We evaluated certainty of evidence using GRADE methodology. PRINCIPAL FINDINGS: No eligible studies included COVID-19 patients. Review 1: 12 RCTs (n = 1,989 patients) provided low-certainty evidence that HFNC may reduce invasive ventilation (relative risk [RR], 0.85; 95% confidence interval [CI], 0.74 to 0.99) and escalation of oxygen therapy (RR, 0.71; 95% CI, 0.51 to 0.98) in patients with respiratory failure. Results provided no support for differences in mortality (moderate certainty), or in-hospital or intensive care length of stay (moderate and low certainty, respectively). Review 2: four studies evaluating droplet dispersion and three evaluating aerosol generation and dispersion provided very low certainty evidence. Two simulation studies and a crossover study showed mixed findings regarding the effect of HFNC on droplet dispersion. Although two simulation studies reported no associated increase in aerosol dispersion, one reported that higher flow rates were associated with increased regions of aerosol density. CONCLUSIONS: High-flow nasal cannula may reduce the need for invasive ventilation and escalation of therapy compared with COT in COVID-19 patients with acute hypoxemic respiratory failure. This benefit must be balanced against the unknown risk of airborne transmission.


Subject(s)
Coronavirus Infections/therapy , Oxygen Inhalation Therapy/methods , Pneumonia, Viral/therapy , Respiratory Insufficiency/therapy , Aerosols , COVID-19 , Cannula , Coronavirus Infections/complications , Coronavirus Infections/mortality , Humans , Pandemics , Pneumonia, Viral/complications , Pneumonia, Viral/mortality , Randomized Controlled Trials as Topic , Respiratory Insufficiency/physiopathology , Respiratory Insufficiency/virology
4.
Arch Dis Child Fetal Neonatal Ed ; 106(6): 627-634, 2021 Nov.
Article in English | MEDLINE | ID: covidwho-1503592

ABSTRACT

OBJECTIVE: To identify risk factors associated with delivery room respiratory support in at-risk infants who are initially vigorous and received delayed cord clamping (DCC). DESIGN: Prospective cohort study. SETTING: Two perinatal centres in Melbourne, Australia. PATIENTS: At-risk infants born at ≥35+0 weeks gestation with a paediatric doctor in attendance who were initially vigorous and received DCC for >60 s. MAIN OUTCOME MEASURES: Delivery room respiratory support defined as facemask positive pressure ventilation, continuous positive airway pressure and/or supplemental oxygen within 10 min of birth. RESULTS: Two hundred and ninety-eight infants born at a median (IQR) gestational age of 39+3 (38+2-40+2) weeks were included. Cord clamping occurred at a median (IQR) of 128 (123-145) s. Forty-four (15%) infants received respiratory support at a median of 214 (IQR 156-326) s after birth. Neonatal unit admission for respiratory distress occurred in 32% of infants receiving delivery room respiratory support vs 1% of infants who did not receive delivery room respiratory support (p<0.001). Risk factors independently associated with delivery room respiratory support were average heart rate (HR) at 90-120 s after birth (determined using three-lead ECG), mode of birth and time to establish regular cries. Decision tree analysis identified that infants at highest risk had an average HR of <165 beats per minute at 90-120 s after birth following caesarean section (risk of 39%). Infants with an average HR of ≥165 beats per minute at 90-120 s after birth were at low risk (5%). CONCLUSIONS: We present a clinical decision pathway for at-risk infants who may benefit from close observation following DCC. Our findings provide a novel perspective of HR beyond the traditional threshold of 100 beats per minute.


Subject(s)
Critical Pathways/standards , Delivery, Obstetric , Electrocardiography/methods , Oxygen Inhalation Therapy , Umbilical Cord , Australia/epidemiology , Cesarean Section/adverse effects , Cesarean Section/methods , Clinical Decision-Making , Constriction , Continuous Positive Airway Pressure/methods , Delivery, Obstetric/adverse effects , Delivery, Obstetric/methods , Delivery, Obstetric/statistics & numerical data , Female , Gestational Age , Heart Rate , Humans , Infant, Newborn , Male , Monitoring, Physiologic/methods , Oxygen Inhalation Therapy/adverse effects , Oxygen Inhalation Therapy/instrumentation , Oxygen Inhalation Therapy/methods , Risk Assessment/methods , Risk Factors , Time-to-Treatment/standards , Time-to-Treatment/statistics & numerical data
5.
Lancet Respir Med ; 9(8): 933-936, 2021 08.
Article in English | MEDLINE | ID: covidwho-1413072

ABSTRACT

The 2012 Berlin definition of acute respiratory distress syndrome (ARDS) provided validated support for three levels of initial arterial hypoxaemia that correlated with mortality in patients receiving ventilatory support. Since 2015, high-flow nasal oxygen (HFNO) has become widely used as an effective therapeutic support for acute respiratory failure, most recently in patients with severe COVID-19. We propose that the Berlin definition of ARDS be broadened to include patients treated with HFNO of at least 30 L/min who fulfil the other criteria for the Berlin definition of ARDS. An expanded definition would make the diagnosis of ARDS more widely applicable, allowing patients at an earlier stage of the syndrome to be recognised, independent of the need for endotracheal intubation or positive-pressure ventilation, with benefits for the testing of early interventions and the study of factors associated with the course of ARDS. We identify key questions that could be addressed in refining an expanded definition of ARDS, the implementation of which could lead to improvements in clinical practice and clinical outcomes for patients.


Subject(s)
COVID-19 , Oxygen Inhalation Therapy/methods , Respiratory Insufficiency , COVID-19/blood , COVID-19/diagnosis , COVID-19/therapy , Early Diagnosis , Humans , Patient Selection , Respiratory Insufficiency/blood , Respiratory Insufficiency/diagnosis , Respiratory Insufficiency/therapy , SARS-CoV-2 , Severity of Illness Index , Time-to-Treatment/standards
8.
Can Respir J ; 2021: 6638048, 2021.
Article in English | MEDLINE | ID: covidwho-1301736

ABSTRACT

Background: High-flow nasal cannula (HFNC) oxygen therapy has been recommended for use in coronavirus disease 2019 (COVID-19) patients with acute respiratory failure and many other clinical conditions. HFNC devices produced by different manufacturers may have varied performance. Whether there is a difference in these devices and the extent of the differences in performance remain unknown. Methods: Four HFNC devices (AIRVO 2, TNI softFlow 50, HUMID-BH, and OH-70C) and a ventilator with an HFNC module (bellavista 1000) were evaluated. The flow was set at 20, 25, 30, 35, 40, 45, 50, 60, 70, and 80 L/min, and the FiO2 was set at 21%, 26%, 30%, 35%, 40%, 45%, 50%, 60%, 70%, 80%, and 90%. Then, one side of the cannulas was clipped to simulate the compression, bending, or blocking of the nasal cannulas. The flow and FiO2 of the delivered gas were recorded and compared among settings and devices. Results: The actual-flow and actual-FiO2 delivered by different settings and devices varied. AIRVO 2 had superior performance in flow and FiO2 accuracy. bellavista 1000 and OH-70C had good performance in the accuracy of actual-flows and actual-FiO2, respectively. bellavista 1000 and HUMID-BH had a larger flow range from 10 to 80 L/min, but only bellavista 1000 could provide a stable flow with an excessive resistance up to 60 L/min. TNI softFlow 50 had the best flow compensation and could provide sufficient flow with excessive resistance at 20-50 L/min. Conclusions: The variation in flow, FiO2 settings, and devices could influence the actual-flow and actual-FiO2 delivered. AIRVO 2 and OH-70C showed better FiO2 accuracy. TNI softFlow 50, bellavista 1000, and HUMID-BH could lower the risk of insufficient flow support due to accidental compression or blocking of the cannulas. In addition, ventilators with HFNC modules provided comparable flow and FiO2 and could be an alternative to standalone HFNC devices.


Subject(s)
Acute Kidney Injury/therapy , COVID-19 , Cannula , Inhalation/physiology , Oxygen Inhalation Therapy , Acute Kidney Injury/etiology , Analysis of Variance , COVID-19/complications , COVID-19/therapy , Cannula/classification , Cannula/standards , Comparative Effectiveness Research , Humans , Materials Testing/methods , Maximal Respiratory Pressures , Oxygen Inhalation Therapy/instrumentation , Oxygen Inhalation Therapy/methods , SARS-CoV-2 , Tidal Volume/physiology
11.
Am J Emerg Med ; 49: 276-286, 2021 11.
Article in English | MEDLINE | ID: covidwho-1281376

ABSTRACT

BACKGROUND: Awake prone positioning (PP) has been used to avoid intubations in hypoxic COVID-19 patients, but there is limited evidence regarding its efficacy. Moreover, clinicians have little information to identify patients at high risk of intubation despite awake PP. We sought to assess the intubation rate among patients treated with awake PP in our Emergency Department (ED) and identify predictors of need for intubation. METHODS: We conducted a multicenter retrospective cohort study of adult patients admitted for known or suspected COVID-19 who were treated with awake PP in the ED. We excluded patients intubated in the ED. Our primary outcome was prevalence of intubation during initial hospitalization. Other outcomes were intubation within 48 h of admission and mortality. We performed classification and regression tree analysis to identify the variables most likely to predict the need for intubation. RESULTS: We included 97 patients; 44% required intubation and 21% were intubated within 48 h of admission. Respiratory oxygenation (ROX) index and P/F (partial pressure of oxygen / fraction of inspired oxygen) ratio measured 24 h after admission were the variables most likely to predict need for intubation (area under the receiver operating characteristic curve = 0.82). CONCLUSIONS: Among COVID-19 patients treated with awake PP in the ED prior to admission, ROX index and P/F ratio, particularly 24 h after admission, may be useful tools in identifying patients at high risk of intubation.


Subject(s)
COVID-19/complications , Hypoxia/therapy , Intubation, Intratracheal/adverse effects , Prone Position , Wakefulness , Emergency Service, Hospital , Female , Humans , Male , Maryland , Middle Aged , Oxygen Inhalation Therapy/methods , Retrospective Studies , Risk Assessment
12.
Respir Med ; 186: 106516, 2021 09.
Article in English | MEDLINE | ID: covidwho-1275693

ABSTRACT

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is transmitted through respiratory droplets, aerosols and close contact. Cross infections occur because viruses spread rapidly among humans. Nineteen percent (19%) of the infected patients developed severe pneumonia and acute respiratory distress syndrome (ARDS). Hypoxemia usually occurs and patients may require oxygen therapy or mechanical ventilation (MV) support. In this article, recently published clinical experience and observational studies were reviewed. Corresponding respiratory therapy regarding different stages of infection is proposed. Infection control principles and respiratory strategies including oxygen therapy, non-invasive respiratory support (NIRS), intubation evaluation, equipment preparation, ventilator settings, special maneuvers comprise of the prone position (PP), recruitment maneuver (RM), extracorporeal membrane oxygenation (ECMO), weaning and extubation are summarized. Respiratory equipment and device disinfection recommendations are worked up. We expect this review article could be used as a reference by healthcare workers in patient care while minimizing the risk of environmental contamination.


Subject(s)
COVID-19/prevention & control , COVID-19/therapy , Critical Care/methods , Critical Illness , Extracorporeal Membrane Oxygenation/methods , Infection Control/methods , Oxygen Inhalation Therapy/methods , Respiration, Artificial/methods , SARS-CoV-2/pathogenicity , COVID-19/complications , COVID-19/transmission , Cannula , Cross Infection/prevention & control , Cross Infection/transmission , Cross Infection/virology , Humans , Hypoxia/etiology , Hypoxia/therapy , Pneumonia, Viral/etiology , Pneumonia, Viral/therapy , Respiratory Distress Syndrome/etiology , Respiratory Distress Syndrome/therapy
13.
Crit Care Med ; 49(7): e693-e700, 2021 07 01.
Article in English | MEDLINE | ID: covidwho-1276256

ABSTRACT

OBJECTIVES: Severe acute respiratory syndrome coronavirus 2 is transmitted through aerosols and droplets. Nasal high-flow therapy could possibly increase the spreading of exhalates from patients. The aim of this study is to investigate whether nasal high-flow therapy affects the range of the expiratory plume compared with spontaneous breathing. DESIGN: Interventional experiment on single breaths of a healthy volunteer. SETTING: Research laboratory at the Bauhaus-University Weimar. SUBJECTS: A male subject. INTERVENTIONS: Videos and images from a schlieren optical system were analyzed during spontaneous breathing and different nasal high-flow rates. MEASUREMENTS AND MAIN RESULTS: The maximal exhalation spread was 0.99, 2.18, 2.92, and 4.1 m during spontaneous breathing, nasal high-flow of 20 L/min, nasal high-flow of 40 L/min, and nasal high-flow of 60 L/min, respectively. Spreading of the expiratory plume in the sagittal plane can completely be blocked with a surgical mask. CONCLUSIONS: Nasal high-flow therapy increases the range of the expiratory air up to more than 4 meters. The risk to pick up infectious particles could be increased within this range. Attachment of a surgical mask over the nasal high-flow cannula blocks the expiratory airstream.


Subject(s)
Cannula , Exhalation , Oxygen Inhalation Therapy/methods , Pulmonary Ventilation , Adult , Disease Transmission, Infectious/prevention & control , Healthy Volunteers , Humans , Male , Microscopy, Video , Respiratory Rate , Tidal Volume
14.
Crit Care ; 25(1): 209, 2021 06 14.
Article in English | MEDLINE | ID: covidwho-1269884

ABSTRACT

BACKGROUND: The effect of awake prone positioning on intubation rates is not established. The aim of this trial was to investigate if a protocol for awake prone positioning reduces the rate of endotracheal intubation compared with standard care among patients with moderate to severe hypoxemic respiratory failure due to COVID-19. METHODS: We conducted a multicenter randomized clinical trial. Adult patients with confirmed COVID-19, high-flow nasal oxygen or noninvasive ventilation for respiratory support and a PaO2/FiO2 ratio ≤ 20 kPa were randomly assigned to a protocol targeting 16 h prone positioning per day or standard care. The primary endpoint was intubation within 30 days. Secondary endpoints included duration of awake prone positioning, 30-day mortality, ventilator-free days, hospital and intensive care unit length of stay, use of noninvasive ventilation, organ support and adverse events. The trial was terminated early due to futility. RESULTS: Of 141 patients assessed for eligibility, 75 were randomized of whom 39 were allocated to the control group and 36 to the prone group. Within 30 days after enrollment, 13 patients (33%) were intubated in the control group versus 12 patients (33%) in the prone group (HR 1.01 (95% CI 0.46-2.21), P = 0.99). Median prone duration was 3.4 h [IQR 1.8-8.4] in the control group compared with 9.0 h per day [IQR 4.4-10.6] in the prone group (P = 0.014). Nine patients (23%) in the control group had pressure sores compared with two patients (6%) in the prone group (difference - 18% (95% CI - 2 to - 33%); P = 0.032). There were no other differences in secondary outcomes between groups. CONCLUSIONS: The implemented protocol for awake prone positioning increased duration of prone positioning, but did not reduce the rate of intubation in patients with hypoxemic respiratory failure due to COVID-19 compared to standard care. TRIAL REGISTRATION: ISRCTN54917435. Registered 15 June 2020 ( https://doi.org/10.1186/ISRCTN54917435 ).


Subject(s)
COVID-19/therapy , Oxygen Inhalation Therapy/methods , Patient Positioning/methods , Prone Position , Respiratory Insufficiency/prevention & control , Adult , COVID-19/complications , Humans , Intensive Care Units , Intubation, Intratracheal/adverse effects , Male , Middle Aged , Respiratory Insufficiency/etiology , Wakefulness
18.
Chest ; 160(1): 74-84, 2021 07.
Article in English | MEDLINE | ID: covidwho-1258346

ABSTRACT

BACKGROUND: Severity of illness in COVID-19 is consistently lower in women. A focus on sex as a biological factor may suggest a potential therapeutic intervention for this disease. We assessed whether adding progesterone to standard of care (SOC) would improve clinical outcomes of hospitalized men with moderate to severe COVID-19. RESEARCH QUESTION: Does short-term subcutaneous administration of progesterone safely improve clinical outcome in hypoxemic men hospitalized with COVID-19? STUDY DESIGN AND METHODS: We conducted a pilot, randomized, open-label, controlled trial of subcutaneous progesterone in men hospitalized with confirmed moderate to severe COVID-19. Patients were randomly assigned to receive SOC plus progesterone (100 mg subcutaneously twice daily for up to 5 days) or SOC alone. In addition to assessment of safety, the primary outcome was change in clinical status on day 7. Length of hospital stay and number of days on supplemental oxygen were key secondary outcomes. RESULTS: Forty-two patients were enrolled from April 2020 to August 2020; 22 were randomized to the control group and 20 to the progesterone group. Two patients from the progesterone group withdrew from the study before receiving progesterone. There was a 1.5-point overall improvement in median clinical status score on a seven-point ordinal scale from baseline to day 7 in patients in the progesterone group as compared with control subjects (95% CI, 0.0-2.0; P = .024). There were no serious adverse events attributable to progesterone. Patients treated with progesterone required three fewer days of supplemental oxygen (median, 4.5 vs 7.5 days) and were hospitalized for 2.5 fewer days (median, 7.0 vs 9.5 days) as compared with control subjects. INTERPRETATION: Progesterone at a dose of 100 mg, twice daily by subcutaneous injection in addition to SOC, may represent a safe and effective approach for treatment in hypoxemic men with moderate to severe COVID-19. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT04365127; URL: www.clinicaltrials.gov.


Subject(s)
COVID-19 , Progesterone/administration & dosage , SARS-CoV-2/isolation & purification , COVID-19/physiopathology , COVID-19/therapy , Clinical Protocols/standards , Drug Monitoring , Humans , Hypoxia/diagnosis , Hypoxia/etiology , Injections, Subcutaneous , Male , Middle Aged , Oxygen Inhalation Therapy/methods , Pilot Projects , Progestins/administration & dosage , Severity of Illness Index , Treatment Outcome
19.
J Med Internet Res ; 23(4): e23446, 2021 04 28.
Article in English | MEDLINE | ID: covidwho-1256230

ABSTRACT

BACKGROUND: With the growing stress on hospitals caused by the COVID-19 pandemic, the need for home-based solutions has become a necessity to support these overwhelmed hospitals. OBJECTIVE: The goal of this study was to compare two nonpharmacological respiratory treatment methods for home-isolated COVID-19 patients using a newly developed telemanagement health care system. METHODS: In this single-blinded randomized clinical trial, 60 patients with stage 1 pneumonia caused by SARS-CoV-2 infection were treated. Group A (n=30) received oxygen therapy with bilevel positive airway pressure (BiPAP) ventilation, and Group B (n=30) received osteopathic manipulative respiratory and physical therapy techniques. Arterial blood gases of PaO2 and PaCO2, pH, vital signs (ie, temperature, respiratory rate, oxygen saturation, heart rate, and blood pressure), and chest computed tomography scans were used for follow-up and for assessment of the course and duration of recovery. RESULTS: Analysis of the results showed a significant difference between the two groups (P<.05), with Group A showing shorter recovery periods than Group B (mean 14.9, SD 1.7 days, and mean 23.9, SD 2.3 days, respectively). Significant differences were also observed between baseline and final readings in all of the outcome measures in both groups (P<.05). Regarding posttreatment satisfaction with our proposed telemanagement health care system, positive responses were given by most of the patients in both groups. CONCLUSIONS: It was found that home-based oxygen therapy with BiPAP can be a more effective prophylactic treatment approach than osteopathic manipulative respiratory and physical therapy techniques, as it can impede exacerbation of early-stage COVID-19 pneumonia. Telemanagement health care systems are promising methods to help in the pandemic-related shortage of hospital beds, as they showed reasonable effectiveness and reliability in the monitoring and management of patients with early-stage COVID-19 pneumonia. TRIAL REGISTRATION: ClinicalTrials.gov NCT04368923; https://clinicaltrials.gov/ct2/show/NCT04368923.


Subject(s)
COVID-19/therapy , Oxygen Inhalation Therapy/methods , Physical Therapy Modalities , Positive-Pressure Respiration/methods , Telemedicine/methods , Adult , COVID-19/epidemiology , Female , Humans , Male , Pandemics , SARS-CoV-2/isolation & purification , Treatment Outcome , Young Adult
20.
JAMA ; 325(17): 1731-1743, 2021 05 04.
Article in English | MEDLINE | ID: covidwho-1241490

ABSTRACT

Importance: High-flow nasal oxygen is recommended as initial treatment for acute hypoxemic respiratory failure and is widely applied in patients with COVID-19. Objective: To assess whether helmet noninvasive ventilation can increase the days free of respiratory support in patients with COVID-19 compared with high-flow nasal oxygen alone. Design, Setting, and Participants: Multicenter randomized clinical trial in 4 intensive care units (ICUs) in Italy between October and December 2020, end of follow-up February 11, 2021, including 109 patients with COVID-19 and moderate to severe hypoxemic respiratory failure (ratio of partial pressure of arterial oxygen to fraction of inspired oxygen ≤200). Interventions: Participants were randomly assigned to receive continuous treatment with helmet noninvasive ventilation (positive end-expiratory pressure, 10-12 cm H2O; pressure support, 10-12 cm H2O) for at least 48 hours eventually followed by high-flow nasal oxygen (n = 54) or high-flow oxygen alone (60 L/min) (n = 55). Main Outcomes and Measures: The primary outcome was the number of days free of respiratory support within 28 days after enrollment. Secondary outcomes included the proportion of patients who required endotracheal intubation within 28 days from study enrollment, the number of days free of invasive mechanical ventilation at day 28, the number of days free of invasive mechanical ventilation at day 60, in-ICU mortality, in-hospital mortality, 28-day mortality, 60-day mortality, ICU length of stay, and hospital length of stay. Results: Among 110 patients who were randomized, 109 (99%) completed the trial (median age, 65 years [interquartile range {IQR}, 55-70]; 21 women [19%]). The median days free of respiratory support within 28 days after randomization were 20 (IQR, 0-25) in the helmet group and 18 (IQR, 0-22) in the high-flow nasal oxygen group, a difference that was not statistically significant (mean difference, 2 days [95% CI, -2 to 6]; P = .26). Of 9 prespecified secondary outcomes reported, 7 showed no significant difference. The rate of endotracheal intubation was significantly lower in the helmet group than in the high-flow nasal oxygen group (30% vs 51%; difference, -21% [95% CI, -38% to -3%]; P = .03). The median number of days free of invasive mechanical ventilation within 28 days was significantly higher in the helmet group than in the high-flow nasal oxygen group (28 [IQR, 13-28] vs 25 [IQR 4-28]; mean difference, 3 days [95% CI, 0-7]; P = .04). The rate of in-hospital mortality was 24% in the helmet group and 25% in the high-flow nasal oxygen group (absolute difference, -1% [95% CI, -17% to 15%]; P > .99). Conclusions and Relevance: Among patients with COVID-19 and moderate to severe hypoxemia, treatment with helmet noninvasive ventilation, compared with high-flow nasal oxygen, resulted in no significant difference in the number of days free of respiratory support within 28 days. Further research is warranted to determine effects on other outcomes, including the need for endotracheal intubation. Trial Registration: ClinicalTrials.gov Identifier: NCT04502576.


Subject(s)
COVID-19/complications , Intubation, Intratracheal/statistics & numerical data , Noninvasive Ventilation/instrumentation , Oxygen Inhalation Therapy/methods , Respiratory Insufficiency/therapy , Aged , COVID-19/mortality , COVID-19/therapy , Female , Hospital Mortality , Humans , Hypoxia/etiology , Male , Middle Aged , Noninvasive Ventilation/methods , Respiratory Insufficiency/etiology , Treatment Failure
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