An interventional study of early extubation of hypoxemic patients in Hypoxemia, Extubation and Postoperative Respiratory Complication, sponsored by Fondation Hôpital Saint-Joseph. Not yet recruiting at 12 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-14.
Sponsored by Fondation Hôpital Saint-Joseph · Not applicable, Interventional, and Treatment
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).
International guidelines recommend extubating patients after correction of hypoxemia, meaning if the SpO2 measured during the spontaneous breathing trial is above 92%. However, there is strong rationale for modifying this practice to extubate patients earlier, particularly those presenting with hypoxemia after major surgery, by using alternating non-invasive ventilation (NIV) and high-flow oxygen therapy:
Several studies have found no link between patient oxygenation and extubation success, where outcomes for hypoxemic and non-hypoxemic patients are similar. Isolated hypoxemia thus does not appear to be a predictor of reintubation.
Hypoxemia is very common following major surgery, primarily due to shunts caused by atelectasis. Treatment for these atelectasis includes airway pressurization, bronchial secretion drainage, mobilization, and reducing factors that lead to diaphragmatic dysfunction.
In patients on invasive mechanical ventilation, secretion drainage is impaired, and mobilization to a seated position is more challenging. It has also been shown that diaphragmatic dysfunction occurs with prolonged ventilation. Hypoxemia can therefore be sustained by invasive ventilation, increasing the risk of therapeutic escalation.
Current guidelines do not account for the widespread use of non-invasive assistance techniques (such as high-flow oxygen therapy and non-invasive ventilation) that are now routinely employed in intensive care. These techniques allow for adequate oxygenation with high patient comfort and good tolerance.
Prolonging invasive ventilation in hypoxemic patients, as recommended by guidelines, could lead to associated complications. In contrast, early extubation of patients with hypoxemia may reduce the duration of both invasive and non-invasive ventilation, as well as complications related to prolonged invasive ventilation, without increasing the risk of reintubation.
Compared to continuing mechanical ventilation until hypoxemia is corrected, extubating purely hypoxemic patients and transitioning them to non-invasive ventilation techniques could represent a significant improvement in patient care.
1,246 studies on the registry are indexed under Hypoxia; 239 are open to participants now.
This study's planned enrollment of 152 is above the median of 45 across 864 interventional studies indexed under Hypoxia.
Browse Hypoxia studies →Fondation Hôpital Saint-Joseph is the lead sponsor of 344 studies on the registry; 49 are open to participants now.
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Exclusion Criteria:
Randomized patients exhibit relative hypoxemia, defined by an SpO2 ≤ 90% while receiving 6 liters of oxygen or FiO2 of 40%. They must not have severe hypoxemia, defined as an SpO2 \< 86% while receiving 9 liters of oxygen or FiO2 of 50%. Additionally, they must not show clinical signs of poor tolerance to the spontaneous breathing trial. Patients randomized to the "hypoxemic extubation group" are extubated despite the presence of relative hypoxemia after one hour of reventilation. Following extubation, a non-invasive oxygenation strategy is initiated, alternating between non-invasive ventilation and high-flow oxygen therapy for a minimum of 24 hours.
Other: early extubation of hypoxemic patients
Patients in the conventional extubation group also present with relative hypoxemia, defined as an SpO2 ≤ 90% on 6 liters of oxygen or FiO2 of 40% at the time of randomization, but they will only be extubated after correction of this hypoxemia. In practice, patients in the conventional extubation group are not extubated after randomization and continue on invasive ventilation. A new spontaneous breathing trial (SBT) can be performed between 2 and 6 hours after randomization, and if unsuccessful, it may be repeated daily at the discretion of the clinician. Patients in the conventional extubation group will only be extubated when their SpO2 exceeds 90% during an SBT conducted on 6 liters of oxygen or FiO2 of 40%. After extubation, a non-invasive oxygenation strategy will be initiated, alternating between non-invasive ventilation (NIV) and high-flow oxygen therapy, for a minimum of 24 hours.
patient 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.
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 randomization
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 ventilation
death
occuring of death during ICU, hospital management and at day 90
Time frame: at 28 and 90 days after randomisation
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 28
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 randomization
non invasive ventilation duration
Time in hours between initiation and cessation of non-invasive support after extubation
Time frame: from date of extubation until the date of cessation of non invasive ventilation strategy or date of reintubation assessed up to 90 days
reintubation rate
Number of patients requiring reintubation
Time frame: up to day 90 after randomisation
Rate of ventilator-associated pneumonia.
Episodes of ventilator-associated pneumonia according to specific definition
Time frame: up to day 90 after randomisation
Rate of pneumonia not acquired under invasive mechanical ventilation
Epiodes of pneumonia not acquired during invasive mechanical ventilation
Time frame: up to 90 days after randomisation
time to mobilisation
time in hours between randomization and the first mobilisation in the chair
Time frame: from date of randomisation until the date of the first chair mobilization or death from any cause whichever came first , assessed up to 90 days after randomization
time to ambulation
time in hours between randomization and first ambulation
Time frame: from date of randomisation until the date of the first ambulation or death from any cause whichever came first , assessed up to 90 days after randomization
length of stay in ICU
number of day between admission and discharge to ICU
Time frame: from date of entrance until the date of discharge to ICU or death from any cause whichever came first assessed up to 52 weeks after randomization
length of stay in ICU after randomisation
number of day between randomisation and discharge from the ICU
Time frame: from randomisation until the date of discharge to ICU or death from any cause whichever came first assessed up to 52 weeks after randomization
length of stay in hospital after randomisation
Time in days from randomisation to hospital discharge
Time frame: from date of randomisation until the date of hospital discharge or death from any cause whichever came first assessed up to 52 weeks after randomization
length of stay in hospital
number of day between admission to discharge of hospital
Time frame: from date of admission until the date of hospital discharge or death from any cause whichever came first assessed up to 52 weeks after randomization
Plan to share: No
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