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Randomized Controlled Trial
. 2019 Oct 15;322(15):1465-1475.
doi: 10.1001/jama.2019.14901.

Effect of Postextubation High-Flow Nasal Oxygen With Noninvasive Ventilation vs High-Flow Nasal Oxygen Alone on Reintubation Among Patients at High Risk of Extubation Failure: A Randomized Clinical Trial

Arnaud W Thille  1   2 , Grégoire Muller  3 , Arnaud Gacouin  4 , Rémi Coudroy  1   2 , Maxens Decavèle  5 , Romain Sonneville  6 , François Beloncle  7 , Christophe Girault  8 , Laurence Dangers  9 , Alexandre Lautrette  10 , Séverin Cabasson  11 , Anahita Rouzé  12 , Emmanuel Vivier  13 , Anthony Le Meur  14 , Jean-Damien Ricard  15 , Keyvan Razazi  16 , Guillaume Barberet  17 , Christine Lebert  18 , Stephan Ehrmann  19 , Caroline Sabatier  20 , Jeremy Bourenne  21 , Gael Pradel  22 , Pierre Bailly  23 , Nicolas Terzi  24 , Jean Dellamonica  25 , Guillaume Lacave  26 , Pierre-Éric Danin  27 , Hodanou Nanadoumgar  28 , Aude Gibelin  29 , Lassane Zanre  30 , Nicolas Deye  31 , Alexandre Demoule  5 , Adel Maamar  4 , Mai-Anh Nay  3 , René Robert  1   2 , Stéphanie Ragot  2 , Jean-Pierre Frat  1   2 ; HIGH-WEAN Study Group and the REVA Research Network
Affiliations
Randomized Controlled Trial

Effect of Postextubation High-Flow Nasal Oxygen With Noninvasive Ventilation vs High-Flow Nasal Oxygen Alone on Reintubation Among Patients at High Risk of Extubation Failure: A Randomized Clinical Trial

Arnaud W Thille et al. JAMA. .

Erratum in

Abstract

Importance: High-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.

Objective: To 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 participants: Multicenter 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.

Interventions: Patients 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 measures: The 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.

Results: Among 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 relevance: In 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 registration: ClinicalTrials.gov Identifier: NCT03121482.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Thille reported receiving grants from the French Ministry of Health and personal fees and nonfinancial support from Fisher & Paykel Healthcare during the conduct of the study and personal fees from Maquet-Getinge, GE Healthcare, and Covidien outside the submitted work. Dr Sonneville reported receiving grants from the French Ministry of Health, the European Society of Intensive Care Medicine, and the French Society of Intensive Care Medicine and personal fees from Baxter outside the submitted work. Dr Beloncle reported receiving personal fees from Lowenstein Medical and nonfinancial support from GE Healthcare, Getinge Group, and Covidien outside the submitted work. Dr Girault reported receiving grants, personal fees, and nonfinancial support from Fisher & Paykel Healthcare during the conduct of the study and grants and nonfinancial support from ResMed outside the submitted work. Dr Ricard reported receiving travel and accommodation expenses from Fisher & Paykel Healthcare outside the submitted work. Dr Ehrmann reported receiving grants, nonfinancial support, and other funding from Fisher & Paykel Healthcare during the conduct of the study; grants, personal fees, nonfinancial support, and other funding from Aerogen; grants from Hamilton; personal fees from La Diffusion Technique Française; and personal fees from Baxter outside the submitted work. In addition, Dr Ehrmann had a patent to EP17305015 issued. Dr Terzi reported receiving personal fees from Boehringer Ingelheim and Pfizer outside the submitted work. Dr Danin reported receiving fees for lectures from Fisher and Paykel during the conduct of the study. Dr Deye reported receiving lecture and travel fees from Zoll and Bard outside the submitted work. Dr Demoule reported receiving personal fees from Medtronic, Baxter, Hamilton, and Getinge; grants, personal fees, and nonfinancial support from Philips and Lungpacer; personal fees and nonfinancial support from Fisher & Paykel Healthcare; and grants from the French Ministry of Health and Respinor outside the submitted work. Dr Frat reported receiving personal fees and nonfinancial support from Fisher & Paykel Healthcare during the conduct of the study and personal fees and nonfinancial support from SOS Oxygen outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Flow of Patients in the HIGH-Wean Trial of High-Flow Nasal Oxygen With or Without Noninvasive Ventilation
aThose at high risk of reintubation were older than 65 years or had an underlying chronic cardiac or lung disease.
Figure 2.
Figure 2.. Kaplan-Meier Analysis of Time From Extubation to Reintubation for the Overall Study Population
The median observation time was 7 days (interquartile range, 7-7) in both treatment groups.
Figure 3.
Figure 3.. Kaplan-Meier Analysis of Time From Extubation to Reintubation According to Predefined Strata
Results in hypercapnic patients with arterial partial pressure of carbon dioxide (Paco2) greater than 45 mm Hg (A) and in nonhypercapnic patients with Paco2 of 45 mm Hg or less (B) are shown. The median observation time was 7 days (interquartile range, 7-7) in both treatment groups.
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