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

NCT04014920 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2025-09-30

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-02
Primary Completion
2021-07-17
Completion
2021-10-22

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04014920 on ClinicalTrials.gov