Status:
COMPLETED
Non-invasive Ventilation Following Extubation (Prophylactic) to Prevent Extubation Failure in Critically Obese Patients
Lead Sponsor:
University Hospital, Montpellier
Conditions:
Obesity
Ventilation
Eligibility:
All Genders
18+ years
Phase:
NA
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 me...
Detailed Description
Mechanical ventilation is the first artificial support used in intensive care unit (ICU). After a period of invasive mechanical ventilation, patients should be separated from the ventilator (weaning p...
Eligibility Criteria
Inclusion
- 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
- Written informed consent from the patient or proxy (if present) before inclusion or once possible when patient has been included in a context of emergency.
Exclusion
- 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)
Key Trial Info
Start Date :
October 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2021
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04014920
Start Date
October 2 2019
End Date
October 22 2021
Last Update
September 30 2025
Active Locations (1)
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1
Centre Hospitalier Universitaire Saint Eloi
Montpellier, Herault, France, 34000