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High-flow nasal oxygen therapy alone or with non-invasive ventilation in immunocompromised patients admitted to ICU for acute hypoxemic respiratory failure: the randomised multicentre controlled FLORALI-IM protocol.

ABSTRACT: INTRODUCTION:Non-invasive ventilation (NIV) is recommended as first-line therapy in respiratory failure of critically ill immunocompromised patients as it can decrease intubation and mortality rates as compared with standard oxygen. However, its recommendation is only conditional. Indeed, the use of NIV in this setting has been challenged recently based on results of trials finding similar outcomes with or without NIV or even deleterious effects of NIV. To date, NIV has been compared with standard oxygen but not to high-flow nasal oxygen therapy (HFOT) in immunocompromised patients. Several studies have found lower mortality rates using HFOT alone than when using HFOT with NIV sessions in patients with de novo respiratory failure, and even in immunocompromised patients. We are hypothesising that HFOT alone is more effective than HFOT with NIV sessions and reduces mortality of immunocompromised patients with acute hypoxemic respiratory failure. METHODS AND ANALYSIS:This study is an investigator-initiated, multicentre randomised controlled trial comparing HFOT alone or with NIV in immunocompromised patients admitted to intensive care unit (ICU) for severe acute hypoxemic respiratory failure. Around 280 patients will be randomised with a 1:1 ratio in two groups. The primary outcome is the mortality rate at day 28 after inclusion. Secondary outcomes include the rate of intubation in each group, length of ICU and hospital stay and mortality up to day 180. ETHICS AND DISSEMINATION:The study has been approved by the ethics committee and patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER:NCT02978300.

SUBMITTER: Coudroy R

PROVIDER: S-EPMC6701687 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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High-flow nasal oxygen therapy alone or with non-invasive ventilation in immunocompromised patients admitted to ICU for acute hypoxemic respiratory failure: the randomised multicentre controlled FLORALI-IM protocol.

Coudroy Rémi R Frat Jean-Pierre JP Ehrmann Stephan S Pène Frédéric F Terzi Nicolas N Decavèle Maxens M Prat Gwenaël G Garret Charlotte C Contou Damien D Bourenne Jeremy J Gacouin Arnaud A Girault Christophe C Dellamonica Jean J Malacrino Dominique D Labro Guylaine G Quenot Jean-Pierre JP Herbland Alexandre A Jochmans Sébastien S Devaquet Jérôme J Benzekri Dalila D Vivier Emmanuel E Nseir Saad S Colin Gwenhaël G Thévenin Didier D Grasselli Giacomo G Assefi Mona M Guerin Claude C Bougon David D Lherm Thierry T Kouatchet Achille A Ragot Stéphanie S Thille Arnaud W AW

BMJ open 20190810 8

<h4>Introduction</h4>Non-invasive ventilation (NIV) is recommended as first-line therapy in respiratory failure of critically ill immunocompromised patients as it can decrease intubation and mortality rates as compared with standard oxygen. However, its recommendation is only conditional. Indeed, the use of NIV in this setting has been challenged recently based on results of trials finding similar outcomes with or without NIV or even deleterious effects of NIV. To date, NIV has been compared wit ...[more]

PMID: 31401603

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Project description:BackgroundThe benefit-risk ratio of prophylactic non-invasive ventilation (NIV) and high-flow nasal oxygen therapy (HFNC-O2) during the early stage of blunt chest trauma remains controversial because of limited data. The main objective of this study was to compare the rate of endotracheal intubation between two NIV strategies in high-risk blunt chest trauma patients.MethodsThe OptiTHO trial was a randomized, open-label, multicenter trial over a two-year period. Every adult patients admitted in intensive care unit within 48 h after a high-risk blunt chest trauma (Thoracic Trauma Severity Score ≥ 8), an estimated PaO2/FiO2 ratio < 300 and no evidence of acute respiratory failure were eligible for study enrollment (Clinical Trial Registration: NCT03943914). The primary objective was to compare the rate of endotracheal intubation for delayed respiratory failure between two NIV strategies: i) a prompt association of HFNC-O2 and "early" NIV in every patient for at least 48 h with vs. ii) the standard of care associating COT and "late" NIV, indicated in patients with respiratory deterioration and/or PaO2/FiO2 ratio ≤ 200 mmHg. Secondary outcomes were the occurrence of chest trauma-related complications (pulmonary infection, delayed hemothorax or moderate-to-severe ARDS).ResultsStudy enrollment was stopped for futility after a 2-year study period and randomization of 141 patients. Overall, 11 patients (7.8%) required endotracheal intubation for delayed respiratory failure. The rate of endotracheal intubation was not significantly lower in patients treated with the experimental strategy (7% [5/71]) when compared to the control group (8.6% [6/70]), with an adjusted OR = 0.72 (95%IC: 0.20-2.43), p = 0.60. The occurrence of pulmonary infection, delayed hemothorax or delayed ARDS was not significantly lower in patients treated by the experimental strategy (adjusted OR = 1.99 [95%IC: 0.73-5.89], p = 0.18, 0.85 [95%IC: 0.33-2.20], p = 0.74 and 2.14 [95%IC: 0.36-20.77], p = 0.41, respectively).ConclusionA prompt association of HFNC-O2 with preventive NIV did not reduce the rate of endotracheal intubation or secondary respiratory complications when compared to COT and late NIV in high-risk blunt chest trauma patients with non-severe hypoxemia and no sign of acute respiratory failure.Clinical trial registrationNCT03943914, Registered 7 May 2019.

Project description:ImportanceHigh-flow nasal oxygen may prevent postextubation respiratory failure in the intensive care unit (ICU). The combination of high-flow nasal oxygen with noninvasive ventilation (NIV) may be an optimal strategy of ventilation to avoid reintubation.ObjectiveTo determine whether high-flow nasal oxygen with prophylactic NIV applied immediately after extubation could reduce the rate of reintubation, compared with high-flow nasal oxygen alone, in patients at high risk of extubation failure in the ICU.Design, setting, and participantsMulticenter randomized clinical trial conducted from April 2017 to January 2018 among 641 patients at high risk of extubation failure (ie, older than 65 years or with an underlying cardiac or respiratory disease) at 30 ICUs in France; follow-up was until April 2018.InterventionsPatients were randomly assigned to high-flow nasal oxygen alone (n = 306) or high-flow nasal oxygen alternating with NIV (n = 342) immediately after extubation.Main outcomes and measuresThe primary outcome was the proportion of patients reintubated at day 7; secondary outcomes included postextubation respiratory failure at day 7, reintubation rates up until ICU discharge, and ICU mortality.ResultsAmong 648 patients who were randomized (mean [SD] age, 70 [10] years; 219 women [34%]), 641 patients completed the trial. The reintubation rate at day 7 was 11.8% (95% CI, 8.4%-15.2%) (40/339) with high-flow nasal oxygen and NIV and 18.2% (95% CI, 13.9%-22.6%) (55/302) with high-flow nasal oxygen alone (difference, -6.4% [95% CI, -12.0% to -0.9%]; P = .02). Among the 11 prespecified secondary outcomes, 6 showed no significant difference. The proportion of patients with postextubation respiratory failure at day 7 (21% vs 29%; difference, -8.7% [95% CI, -15.2% to -1.8%]; P = .01) and reintubation rates up until ICU discharge (12% vs 20%, difference -7.4% [95% CI, -13.2% to -1.8%]; P = .009) were significantly lower with high-flow nasal oxygen and NIV than with high-flow nasal oxygen alone. ICU mortality rates were not significantly different: 6% with high-flow nasal oxygen and NIV and 9% with high-flow nasal oxygen alone (difference, -2.4% [95% CI, -6.7% to 1.7%]; P = .25).Conclusions and relevanceIn mechanically ventilated patients at high risk of extubation failure, the use of high-flow nasal oxygen with NIV immediately after extubation significantly decreased the risk of reintubation compared with high-flow nasal oxygen alone.Trial registrationClinicalTrials.gov Identifier: NCT03121482.

Project description:ObjectivesLimited evidence is available regarding the role of high-flow nasal oxygen in the management of acute hypoxemic respiratory failure secondary to coronavirus disease 2019. Our objective was to characterize outcomes associated with high-flow nasal oxygen use in critically ill adult patients with coronavirus disease 2019-associated acute hypoxemic respiratory failure.DesignObservational cohort study between March 18, 2020, and June 3, 2020.SettingNine ICUs at three university-affiliated hospitals in Philadelphia, PA.PatientsAdult ICU patients with confirmed coronavirus disease 2019 infection admitted with acute hypoxemic respiratory failure.InterventionsNone.Measurements and main resultsOf 266 coronavirus disease 2019 ICU admissions during the study period, 124 (46.6%) received some form of noninvasive respiratory support. After exclusions, we analyzed 83 patients who were treated with high-flow nasal oxygen as a first-line therapy at or near the time of ICU admission. Patients were predominantly male (63.9%). The most common comorbidity was hypertension (60.2%). Progression to invasive mechanical ventilation was common, occurring in 58 patients (69.9%). Of these, 30 (51.7%) were intubated on the same day as ICU admission. As of June 30, 2020, hospital mortality rate was 32.9% and the median hospital length of stay was 15 days. Among survivors, the most frequent discharge disposition was home (51.0%). In comparing patients who received high-flow nasal oxygen alone (n = 54) with those who received high-flow nasal oxygen in conjunction with noninvasive positive-pressure ventilation via face mask (n = 29), there were no differences in the rates of endotracheal intubation or other clinical and utilization outcomes.ConclusionsWe observed an overall high usage of high-flow nasal oxygen in our cohort of critically ill patients with acute hypoxemic respiratory failure secondary to coronavirus disease 2019. Rates of endotracheal intubation and mortality in this cohort were on par with and certainly not higher than other published series. These findings should prompt further considerations regarding the use of high-flow nasal oxygen in the management algorithm for coronavirus disease 2019-associated acute hypoxemic respiratory failure.

Dataset Information

High-flow nasal oxygen therapy alone or with non-invasive ventilation in immunocompromised patients admitted to ICU for acute hypoxemic respiratory failure: the randomised multicentre controlled FLORALI-IM protocol.

Publications

High-flow nasal oxygen therapy alone or with non-invasive ventilation in immunocompromised patients admitted to ICU for acute hypoxemic respiratory failure: the randomised multicentre controlled FLORALI-IM protocol.

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