Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT04014920
NA

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

Sponsor: University Hospital, Montpellier

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1000

Start Date

2019-10-02

Completion Date

2021-10-22

Last Updated

2026-06-15

Healthy Volunteers

No

Interventions

DEVICE

Oxygen group

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

DEVICE

NIV Group

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

Locations (1)

Centre Hospitalier Universitaire Saint Eloi

Montpellier, Herault, France