Effect of non-invasive ventilation after extubation in critically ill patients with obesity in France: a multicentre, unblinded, pragmatic randomised clinical trial

Jong, Audrey De; Bignon, Anne; Stéphan, François; Godet, Thomas; Constantin, Jean-Michel; Asehnoune, Karim; Sylvestre, Aude; SAUTILLET, JULIETTE; Blondonnet, Raïko; Ferrandière, Martine; Séguin, Philippe; Lasocki, Sigismond; Rolle, Amélie; Fayolle, Pierre-Marie; Muller, Laurent; Pardo, Emmanuel; Terzi, Nicolas; Ramin, Séverin; Jung, Boris; Abback, Paër-Sélim; Guerci, Philippe; Sarton, Benjamine; Rozé, Hadrien; Dupuis, Claire; Cousson, J.; Faucher, Marion; Lemiale, Virginie; Cholley, Bernard; Chanques, Gérald; Belafia, Fouad; Huguet, Hélèna; Futier, Emmanuel; GNIADEK, CLAUDINE; VONARB, AURELIE; Prades, Albert; JAILLET, CARINE; Capdevila, Xavier; Charbit, Jonathan; Genty, Thibaut; Rézaiguia-Delclaux, Saïda; Imbert, Audrey; Pilorge, Catherine; CALYPSO, ROMAN; BOUTEAU-DURAND, ASTRID; Carlès, Michel; MEHDAOUI, HOSSEN; Souweine, Bertrand; CALVET, LAURE; Jabaudon, Matthieu; Rieu, Benjamin; CANDILLE, CLARA; SIGAUD, FLORIAN; Riu, Béatrice; Papazian, Laurent; Valéra, Sabine; MOKART, DJAMEL; CHINE, LAURENT CHOW; Bisbal, Magali; POULIQUEN, CAMILLE; GUIBERT, JEAN-MANUEL DE; TOURRET, MAXIME; Mallet, Damien; Leone, Marc; ZIELESKIEWICZ, LAURENT; COSSIC, JEANNE; Assefi, Mona; Baron, Ėlodie; Quemeneur, Cyril; Monsel, Antoine; Biais, Matthieu; Ouattara, Alexandre; BONNARDEL, ELINE; MONZIOLS, SIMON; Mahul, Martin; Lefrant, Jean‐Yves; Roger, Claire; BARBAR, SABER; Lambiotte, Fabien; Saint-Léger, P.; PAUGAM, CATHERINE; Pottecher, Julien; LUDES, PIERRE-OLIVIER; DARRIVERE, LUCIE; Garnier, Marc; Kipnis, Éric; LEBUFFE, GILLES; GAROT, MATTHIAS; FALCONE, JEREMY; Chousterman, Benjamin; COLLET, MAGALI; Gayat, Étienne; Dellamonica, Jean; MFAM, WILLY-SERGE; OCHIN, EVELINA; NEBLI, MOHAMED; TILOUCHE, NEJLA; Madeux, Benjamin; Bougon, David; Aarab, Yassir; GARNIER, FANNY; Azoulay, Élie; Molinari, Nicolas; Jaber, Samir

doi:10.1016/s2213-2600(22)00529-x

Cited by 12 publications

(5 citation statements)

References 28 publications

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“…To our knowledge, this is the rst study to assess curative NIV in patients with obesity in postoperative of abdominal surgery (14,31). The strengths of the present study are its multicenter design, the explicit criteria for reintubation, and a complete postoperative follow-up.…”

Section: Discussionmentioning

confidence: 99%

“…Future research should investigate whether high-ow nasal oxygenation and/or continuous positive airway pressure (CPAP) have a place, either on curative or prophylactic strategies after abdominal surgery in patients with obesity (14,24,(33)(34)(35).…”

Section: Discussionmentioning

confidence: 99%

“…We performed a large multicenter randomized controlled trial (EXTUB-OBESE trial) (14) involving 981 patients with obesity compared post-extubation prophylactic NIV to oxygenation strategies (high-ow nasal oxygen or standard oxygen) to prevent extubation failure in ICU. This study (14) showed no signi cant difference in reintubation at day-3 in the intention-to-treat analysis but a signi cant lower rate of reintubation at day-3 in the NIV group in the per-protocol analysis.…”

Section: Introductionmentioning

confidence: 99%

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Noninvasive ventilation on reintubation in patients with obesity and hypoxemic respiratory failure following abdominal surgery A post-hoc analysis of a Randomized Clinical Trial

JABER,

Pensier,

Futier

et al. 2024

Preprint

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Purpose Although noninvasive ventilation (NIV) may reduce reintubation in patients with acute hypoxemic respiratory failure following abdominal surgery, this strategy has not been specifically assessed in patients with obesity. Methods We conducted a post-hoc analysis of a multicenter randomized controlled trial comparing NIV delivered via facial mask (inspiratory pressure support level, 5-15cmH2O; positive end-expiratory pressure, 5-10cmH2O; fraction of inspired oxygen titrated to Spo2 ≥ 94%) to standard oxygen-therapy (up to 15 L/min to SpO2 ≥ 94%) among patients with obesity and acute hypoxemic respiratory failure within seven days after abdominal surgery. The primary outcome was reintubation within seven days. Secondary outcomes were invasive ventilation–free days at day 30, Intensive Care Unit (ICU)-acquired pneumonia and 30-day survival. Results Among 293 patients with hypoxemic respiratory failure following abdominal surgery, 76 (26%) patients had obesity and were included in the intention-to-treat analysis. Reintubation rate was significantly lower with NIV (13/42, 31%) than with standard oxygen-therapy (19/34, 56%) within seven days (absolute difference: -25%, 95%Confidence Interval(CI) -49% to -1%, p = 0.03). NIV was associated with significantly more invasive ventilation–free days compared with standard oxygen-therapy (27.1 ± 8.6 vs 22.7 ± 11.1 days; p = 0.02), while fewer patients developed ICU-acquired pneumonia (1/42, 2% vs 6/34, 18%; absolute difference, − 16%; 95%CI, − 31% to − 1%; p = 0.04). The 30-day survival was 98% in the NIV group (41/42) versus 85% in the standard oxygen-therapy (absolute difference, 13%; 95%CI, − 3–28%; p = 0.08). Conclusions Among patients with obesity and hypoxemic respiratory failure following abdominal surgery, use of NIV compared with standard oxygen-therapy reduced the risk of reintubation within seven days. Trial Registration clinicaltrials.gov Identifier: NCT01971892

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Noninvasive ventilation on reintubation in patients with obesity and hypoxemic respiratory failure following abdominal surgery A post-hoc analysis of a Randomized Clinical Trial

JABER,

Pensier,

Futier

et al. 2024

Preprint

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“…In keeping with this study, we found that the higher the body-mass index, the lower the risk of reintubation. This could be explained by the fact that patients with obesity are particularly good responders to noninvasive ventilation, with a rate of reintubation particularly low once under positive pressure [ 28 , 29 ]. A recent study including only patients at high risk of extubation failure, i.e., older than 65 years or with underlying cardiac or chronic lung disease, reported a rate of reintubation among the 112 obese patients receiving noninvasive ventilation of only 6% within the 7 days following extubation, and only 2% at 48 h [ 28 ].…”

Section: Discussionmentioning

confidence: 99%

Sex difference in the risk of extubation failure in ICUs

Thille,

Boissier,

Coudroy

et al. 2023

Ann. Intensive Care

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Background Little attention has been paid to potential differences in prognosis between mechanically ventilated males and females in intensive care units (ICUs). We hypothesized that a sex gap in the risk of extubation failure in ICUs may exist. Methods Post hoc analysis of a large-scale clinical trial including patients at high risk of extubation failure in ICUs, with the aim of assessing the risk of extubation failure according to sex. The primary outcome was reintubation within the 7 days following extubation. Results Out of 641 patients, 425 (66%) were males and 216 (34%) were females. Males were more likely to be admitted for cardiac arrest and to have underlying ischemic heart disease whereas females were more likely to be admitted for coma and to have obesity. Whereas the rate of reintubation at 48 h was significantly higher in males than in females (11.0% vs. 6.0%; difference, + 5.0 [95% CI, 0.2 to 9.2]; P = 0.038), the rate of reintubation at day 7 did not significantly differ between males and females (16.7% vs. 11.1%; difference, + 5.6% [95%CI, − 0.3 to 10.8], P = 0.059). Using multivariable logistic regression analysis, male sex was independently associated with reintubation within the 7 days following extubation (adjusted OR 1.70 [95% CI, 1.01 to 2.89]; P = 0.048), even after adjustment on reason for admission, body-mass index, severity score, respiratory rate before extubation, and noninvasive ventilation after extubation. Conclusion In this post hoc analysis of a clinical trial including a homogeneous subset of patients at high risk of extubation failure, sex was independently associated with reintubation. The role of sex on outcomes should be systematically examined in future studies of critically ill patients.

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“…These trials indicate that, in low-risk patients, HFNO does not reduce the rate of endotracheal intubation vs. conventional oxygenation devices if patients treated with conventional oxygen can receive escalation of respiratory support with noninvasive ventilation before reintubation [ 10 ]. In high-risk patients (e.g., pre-existing respiratory or cardiac disease, or age > 65 years), alternating HFNO with noninvasive ventilation improves outcome compared to HFNO alone, especially in case of obesity [ 11 ]. In very high-risk patients, continuous noninvasive ventilation applied for 48 h seems to perform better than HFNO alone [ 12 ].…”

Section: Patients Undergoing Weaning From Mechanical Ventilationmentioning

confidence: 99%