Health Trials

About this trial

The objective of this clinical trial is to assess whether early extubation of patients with hypoxemia during the spontaneous breathing trial (SBT) shortens the duration of ventilatory support. The trial will also evaluate the safety of this approach. The key research questions include:

Does early extubation of hypoxemic patients reduce the total duration of ventilatory support (both invasive and non-invasive) by 36 hours? Does early extubation of hypoxemic patients increase the number of ventilator-free days by day 28? Can the safety of early extubation in hypoxemic patients be ensured by confirming no significant differences in rates of reintubation, tracheostomy, or mortality? The trial will compare ventilatory outcomes between two groups: hypoxemic patients who undergo early extubation (hypoxemic extubation group) and those who remain on invasive ventilation until hypoxemia resolves (conventional extubation group).

Eligibility criteria

Qualifiers

Francophone patient affiliated to a health insurance plan;

Patient having granted free, informed and written consent to participate in the study;

Patient with hypoxemia defined as SpO2 ≤ 90% under 6 L/min or FiO2 40% during spontaneous breathing trial.

Disqualifiers

Presence of hypercapnia at the end of SBT (PaCO2 above 50 mmHg);

Presence of severe hypoxemia during SBT defined by SpO2 below 86% under 9 L/min or FiO2 = 50%;

Presence of poor clinical tolerance of SBT defined by polypnoea above 30/min, agitation, sweating, hypertension (PAS above 180 mmHg), tachycardia (HR above 140 bpm) or arrhythmia;

Presence of an ineffective cough or major bronchial congestion;

Trial design

Treatments tested in this trial

  • early extubation of hypoxemic patients

Treatment groups

152 Participants
are divided into 2 treatment groups

Locations

12
centre hospitalier Victor Dupouy95107, Argenteuil France
CHRU de Besançon25030, Besançon France
Marie Lannelongue Hospital92350, Le Plessis-Robinson France
Hôpital Saint Eloi, CHU Montpellier34090, Montpellier France

Sponsors and collaborators

Fondation Hôpital Saint-Joseph

Lead sponsor

Source ClinicalTrials.gov