Postoperative Extubation in Hypoxemic Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondation Hôpital Saint-Joseph
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
early extubation of hypoxemic patients
Other interventionpatient extubated after the spontaneous ventilation trial despite the presence of hypoxemia defined by SpO2 ≤ 90% either in T-piece under 6 L/min, or under FiO2 = 40% if SBT is performed in spontaneous ventilation with minimal inspiratory assistance.
Treatment groups
152 Participants
are divided into 2 treatment groupsGroup A: hypoxemic extubation groupExperimental treatment 1 intervention
Group B: conventional extubation groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
time to ventilatory weaning
Time in hours from randomization to discontinuation of ventilatory support (invasive and non-invasive).
Time frame
from date of randomisation until the date of cessation of non invasive ventilation or death from any cause, assessed up to 90 days after randomizationSecondary outcomes
1
neuromyopathie score
MRC score assessed in each group on day 7 of randomisation and on the day of weaning from non-invasive ventilation.
Time frame
day 7of randomisation/day of weaning from non-invasive ventilation2
death
occuring of death during ICU, hospital management and at day 90
Time frame
at 28 and 90 days after randomisation3
ventilatory support duration between randomization and day 28
Number of days alive without ventilation (invasive or non-invasive) at day 28 of randomization.
Time frame
from randomisation to day 284
invasive ventilation duration
Time in hours between randomization and cessation of invasive ventilation
Time frame
from date of randomisation until the date of cessation of invasive ventilation or death from any cause whichever came first assessed up to 90 days after randomizationSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: