Non-invasive Ventilation Following Extubation (Prophylactic) to Prevent Extubation Failure in Critically Obese Patients

NCT04014920 | Completed

• 1 other identifier: 19_0068
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Mechanical ventilation is the first artificial support used in intensive care. After a period of invasive mechanical ventilation, patients should be separated from the ventilator (weaning period of mechanical ventilation). If weaning and extubation (removal of the tracheal tube) are successful in approximately 80 to 90% of resuscitation patients, 10 to 20% will develop acute respiratory failure (ARF) in the days following extubation. Obesity concerns 20 to 30% of resuscitation admissions in France. The pathophysiological changes in the obese patient explain the over-risk of desaturation and ARF in the post-extubation period. In order to decrease the incidence of extubation failure (need for reintubation within 48-72h post-extubation) of the most fragile patients, it is recommended in intensive care unit to prophylactically use various ventilatory support strategies and / or oxygenation, among which noninvasive ventilation (NIV) and oxygen therapy, which can be administered in two ways: High-Flow Humidified Nasal Oxygen Therapy (HFNO) or standard oxygen therapy. These strategies have never been compared in the obese post-extubation critically ill patient. Our hypothesis is that NIV is superior to oxygen to prevent the development of ARF in obese extubated patients in intensive care unit.

Conditions

Obesity; Ventilation; Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

• The failure of the treatment, defined by a composite criteria

  The failure of the treatment, defined by a composite criteria combining the treatment failure, defined as reintubation for mechanical ventilation, switch to the other study treatment, or premature study-treatment discontinuation

  72 hours

Secondary Outcomes (6)

• Incidence of acute respiratory failure

  up to Day 7

• Oxygenation

  Up to Day 7

• Organ failure

  Up to Day 7

• ICU all-cause mortality

  up to day 28

• Tracheal intubation rate

  up to day 28

Study Arms (2)

Oxygen Group

ACTIVE COMPARATOR

Patient will receive standard oxygenotherapy

Device: Oxygen group

NIV Group

EXPERIMENTAL

Patient will receive non invasive ventilation

Device: NIV Group

Interventions

Oxygen group DEVICE

The control group will receive oxygen (first randomization), HFNO oxygen or standard oxygen (second randomization)

Oxygen Group

NIV Group DEVICE

The experimental group will receive NIV (first randomization) alternated with HFNO or standard oxygen (second randomization)

NIV Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (age ≥ 18 years)
• Subjects must be covered by public health insurance
• Obese patients defined by a body mass index ≥ 30 kg/m²
• Extubation after a length of mechanical ventilation \>= 6 hours

You may not qualify if:

• Refusal of study participation or to pursue the study by the patient
• Hypercapnia with a formal indication for NIV (PaCO2 ≥ 50 mmHg, formal indication for NIV)
• Isolated cardiogenic pulmonary edema (formal indication for NIV). Patients with pulmonary edema associated with another ARF etiology can be included.
• Pregnancy or breastfeeding
• Anatomical factors precluding the use of NIV and/or HFNO
• Absence of coverage by the French statutory healthcare insurance system
• Patients with tracheostomy
• Patients with CPAP for obstructive apnea syndrome
• Patients with decision of no-reintubate (limitation)

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Centre Hospitalier Universitaire Saint Eloi

Montpellier, Herault, 34000, France

Location

Related Publications (4)

• De Jong A, Huguet H, Molinari N, Jaber S. Non-invasive ventilation versus oxygen therapy after extubation in patients with obesity in intensive care units: the multicentre randomised EXTUB-OBESE study protocol. BMJ Open. 2022 Jan 19;12(1):e052712. doi: 10.1136/bmjopen-2021-052712.

  PMID: 35045999 BACKGROUND

• De Jong A, Bignon A, Stephan F, Godet T, Constantin JM, Asehnoune K, Sylvestre A, Sautillet J, Blondonnet R, Ferrandiere M, Seguin P, Lasocki S, Rolle A, Fayolle PM, Muller L, Pardo E, Terzi N, Ramin S, Jung B, Abback PS, Guerci P, Sarton B, Roze H, Dupuis C, Cousson J, Faucher M, Lemiale V, Cholley B, Chanques G, Belafia F, Huguet H, Futier E, Azoulay E, Molinari N, Jaber S; EXTUB-OBESE trial group. Effect of non-invasive ventilation after extubation in critically ill patients with obesity in France: a multicentre, unblinded, pragmatic randomised clinical trial. Lancet Respir Med. 2023 Jun;11(6):530-539. doi: 10.1016/S2213-2600(22)00529-X. Epub 2023 Jan 21.

  PMID: 36693403 BACKGROUND

• De Jong A, Huguet H, Bignon A, Stephan F, Godet T, Collet L, Asehnoune K, Sylvestre A, Sautillet J, Blondonnet R, Ferrandiere M, Launey Y, Lasocki S, Rolle A, Fayolle PM, Muller L, Pardo E, Terzi N, Ramin S, Jung B, Weiss E, Abback PS, Guerci P, Sarton B, Roze H, Dupuis C, Cousson J, Faucher M, Lemiale V, Cholley B, Chanques G, Belafia F, Chauveton C, Futier E, Azoulay E, Molinari N, Jaber S; EXTUB-OBESE trial group. Noninvasive ventilation in postoperative critically ill patients with morbid obesity: secondary analysis of the EXTUBOBESE multicentre randomised clinical trial. Br J Anaesth. 2025 Nov;135(5):1477-1485. doi: 10.1016/j.bja.2025.09.002. Epub 2025 Oct 3.

  PMID: 41046173 DERIVED

• De Jong A, Capdevila M, Aarab Y, Rabboni F, Kozoriz A, Heupel G, Pensier J, Lakbar I, Monet C, Chanques G, Jaber S. Norepinephrine use at extubation in critically ill patients with obesity: a cohort study with multicenter validation. Intensive Care Med. 2025 Dec;51(12):2341-2353. doi: 10.1007/s00134-025-08066-x. Epub 2025 Aug 6.

  PMID: 40768069 DERIVED

MeSH Terms

Conditions

Obesity; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 10, 2019
• Study Start: October 2, 2019
• Primary Completion: July 17, 2021
• Study Completion: October 22, 2021
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 12 months after the main publication
• Access Criteria: Data are provided to qualified investigators free of charge. Required documents to request data include a summary of the research plan, request form, and IRB review. Dataset will be shared after careful examination by the study board of investigators.

Locations

FR (1)