CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,000 enrolled / 1,000 target
Drug / intervention
Oxygen group +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04014920
NCT04014920N/ACompletedHigh Momentum (12.3/mo)Completion was 59mo ago

Non-invasive Ventilation Following Extubation (Prophylactic) to Prevent Extubation Failure in Critically Obese Patients: a Prospective, Randomized, Multicenter Study

University Hospital, Montpellier·interventional·Posted Jul 10, 2019·Updated Jun 15, 2026

In Brief

A clinical study evaluating Oxygen group and NIV Group for Obesity and 2 related conditions. Completed, enrolled 1,000 participants across 1 site.

Signals

Enrolling ahead of pace

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJul 10, 2019
Enrollment StartOct 2, 2019
Primary CompletionJul 17, 2021
Study CompletionOct 22, 2021
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 7.0 years ago

Arms & Interventions

Oxygen Groupactive_comparator

Patient will receive standard oxygenotherapy

Device: Oxygen group
NIV Groupexperimental

Patient will receive non invasive ventilation

Device: NIV Group

Interventions

Oxygen groupdevice

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

NIV Groupdevice

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