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ObjectivesTo examine whether high flow nasal oxygen (HFNO), continuous positive airway pressure (CPAP), or noninvasive ventilation (NIV) strategies impact mortality, the need for invasive mechanical ventilation (IMV), or hospital and intensive care unit (ICU) length of stay compared to standard oxygen therapy (SOT) or each other in patients with severe or critical COVID-19 with acute hypoxemic respiratory failure.MethodsA rapid review of randomized controlled trials (RCTs) identified through published systematic and rapid reviews supplemented with a search of bibliographic databases. RCTs were eligible if they compared HFNO, CPAP, or NIV to SOT or another ventilation strategy. Studies were screened, selected, and extracted by a single reviewer and checked by a second reviewer. We assessed risk of bias of included studies using the Cochrane ‘Risk of bias’ tool and used the grading of recommendations, assessment, development, and evaluation (GRADE) approach to judge the certainty of the evidence for mortality, need for IMV, and hospital and ICU length of stay. We sought RCT evidence for non-COVID-19 patients with acute hypoxemic respiratory failure and acute respiratory distress to inform additional comparisons and to supplement the available data for COVID-19.ResultsA total of 5 RCTs comparing ventilation strategies in patients with severe or critical COVID-19 were included. Patient and study characteristics were extracted and evidence and certainty of evidence assessments were completed for comparisons of HFNO and CPAP to standard oxygen therapy and NIV and CPAP to HFNO. An additional 22 RCTs of non-COVID-19 patients were also included and considered.Results from meta-analysis suggest reductions in mortality and IMV with HFNO (RR mortality 0.87 (0.66-1.13), IMV 0.89 (0.77-1.03); low quality evidence) or CPAP (RR mortality 0.87 (0.64-1.18) low quality evidence, IMV 0.81 (0.67-0.98) moderate quality evidence) compared to SOT. Helmet NIV may reduce IMV (RR 0.69 (0.43-1.09)) and CPAP may reduce IMV (RR 0.69 (0.43-1.09)) and hospital (1.67 days fewer (5.43 fewer-2.09 more) or ICU length of stay (1.02 days fewer (3.97 fewer-1.93 more)) compared to HFNO (low quality evidence).ConclusionsThis rapid systematic review highlights the available evidence to support the use of noninvasive ventilation strategies including high flow nasal oxygen, noninvasive ventiltaion (e.g., BiPAP), or CPAP in hospitalized patients with severe or critical COVID-19 and acute hypoxemic respiratory failure who do not need emergent intubation. Findings based on moderate to very low certainty evidence suggest that noninvasive ventilation may be considered as an alternative to standard oxygen therapy to reduce hypoxemia and dyspnea. Additional high quality RCTs are warranted to reduce uncertainty and to fill in important knowledge gaps.
ObjectivesTo examine whether high flow nasal oxygen (HFNO), continuous positive airway pressure (CPAP), or noninvasive ventilation (NIV) strategies impact mortality, the need for invasive mechanical ventilation (IMV), or hospital and intensive care unit (ICU) length of stay compared to standard oxygen therapy (SOT) or each other in patients with severe or critical COVID-19 with acute hypoxemic respiratory failure.MethodsA rapid review of randomized controlled trials (RCTs) identified through published systematic and rapid reviews supplemented with a search of bibliographic databases. RCTs were eligible if they compared HFNO, CPAP, or NIV to SOT or another ventilation strategy. Studies were screened, selected, and extracted by a single reviewer and checked by a second reviewer. We assessed risk of bias of included studies using the Cochrane ‘Risk of bias’ tool and used the grading of recommendations, assessment, development, and evaluation (GRADE) approach to judge the certainty of the evidence for mortality, need for IMV, and hospital and ICU length of stay. We sought RCT evidence for non-COVID-19 patients with acute hypoxemic respiratory failure and acute respiratory distress to inform additional comparisons and to supplement the available data for COVID-19.ResultsA total of 5 RCTs comparing ventilation strategies in patients with severe or critical COVID-19 were included. Patient and study characteristics were extracted and evidence and certainty of evidence assessments were completed for comparisons of HFNO and CPAP to standard oxygen therapy and NIV and CPAP to HFNO. An additional 22 RCTs of non-COVID-19 patients were also included and considered.Results from meta-analysis suggest reductions in mortality and IMV with HFNO (RR mortality 0.87 (0.66-1.13), IMV 0.89 (0.77-1.03); low quality evidence) or CPAP (RR mortality 0.87 (0.64-1.18) low quality evidence, IMV 0.81 (0.67-0.98) moderate quality evidence) compared to SOT. Helmet NIV may reduce IMV (RR 0.69 (0.43-1.09)) and CPAP may reduce IMV (RR 0.69 (0.43-1.09)) and hospital (1.67 days fewer (5.43 fewer-2.09 more) or ICU length of stay (1.02 days fewer (3.97 fewer-1.93 more)) compared to HFNO (low quality evidence).ConclusionsThis rapid systematic review highlights the available evidence to support the use of noninvasive ventilation strategies including high flow nasal oxygen, noninvasive ventiltaion (e.g., BiPAP), or CPAP in hospitalized patients with severe or critical COVID-19 and acute hypoxemic respiratory failure who do not need emergent intubation. Findings based on moderate to very low certainty evidence suggest that noninvasive ventilation may be considered as an alternative to standard oxygen therapy to reduce hypoxemia and dyspnea. Additional high quality RCTs are warranted to reduce uncertainty and to fill in important knowledge gaps.
ImportanceHelmet 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.ObjectiveTo 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 ParticipantsThis 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.InterventionsPatients 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 MeasuresThe 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.ResultsAmong 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 RelevanceResults 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 RegistrationClinicalTrials.gov Identifier: NCT04477668
Australia's national living guidelines for COVID‐19 were launched in April 2020 and include over 200 recommendations to guide the clinical care of patients with COVID‐19. Until the guidelines were retired in August 2023, new evidence was continually monitored through daily surveillance. This paper describes the initial design for evidence surveillance (at a time when efforts to collate information on the novel coronavirus were in their infancy and often duplicative) and how it was refined throughout the pandemic. Among the wide range of sources monitored, the collections of COVID‐19 research from leading medical journals, medRxiv preprints and PubMed auto alerts proved the most enduring in identifying time‐critical and impactful evidence. The paper also explores how evidence was tracked and surveillance integrated into the overall evidence workflow by using messaging apps and communication platforms. Finally, we consider the implications for living guidelines and reflect on factors that contributed to the feasibility of daily surveillance: the clearly defined scope of the guidelines; focusing efforts on maximum impact; minimizing duplication by partnering with others; setting up simple but effective processes for managing evidence; and the value of continuous involvement of personnel from the outset. Australia's living COVID‐19 guidelines were underpinned by a novel approach to evidence surveillance that was feasible and essential in maintaining COVID‐19 living guidelines for over 3 years.
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