Hôpital Pitié Salpêtrière
Paris, 75013, France
Location status: Recruiting
NCT Number: NCT07019636
This randomized controlled open label trial aims at comparing a weaning strategy including a spontaneous breathing trial as a prerequisite for extubation to a weaning strategy without a spontaneous breathing trial (direct extubation) in patients with readiness to be weaned criteria and considered at low risk of extubation failure. The main endpoint will be the proportion of patients successfully extubated within the 24 hours after randomization as compared to extubation after a successful spontaneous breathing trial (SBT).
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Paris, 75013, France
Location status: Recruiting
Weaning from mechanical ventilation is a critical step in the course on an ICU stay. Separation from the ventilator should be done at the earliest possible time, but extubation failure is an adverse event that should be avoided. The most common decision-making strategy regarding weaning and extubation is to combine a daily assessment of the patient's "readiness to wean" and a spontaneous breathing trial before to extubate.
The result of the SBT (passed of failed) is often viewed as a "go - no go" indicator of whether or not patients are ready for extubation, but daily practice indicates that the assessment of the SBT is subjective with a frequent natural tendency for clinicians to keep their patients on the 'safe' side, i.e., considering them as not being ready for extubation. However, the results of the SBT should be interpreted based on the pre-test probability. Conducting a SBT in patients while the pre-test probability of success is high will result in false negatives which are likely to delay the decision of extubation. In addition, a pointless SBT may expose patients to anxiety, air hunger and dyspnea which are poorly detected by caregivers. The hypothesis of the present project is that in patients who are at low risk of extubation failure, a SBT is useless and once readiness to wean criteria are met, direct extubation would increase the proportion of patients successfully extubated within the 24 hours after randomization as compared to extubation after a successful SBT.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will be extubated within the 60 minutes following randomization
Patients will undergo a spontaneous breathing trial and will be extubated only in case of successful spontaneous breathing
Time frame: From Day 1 to Day 3
The rate of patients extubated within the 24 hours after randomization and who will remain free from mechanical ventilation until 72 hours.
Time frame: Within 28 days after randomization
Rate of post extubation acute respiratory failure defined by the persistence of more than 30 minutes of at least two predefined criteria
Time frame: Within 28 days after randomization
Rate of of reintubation with predefined criteria
Time frame: Within 28 days after randomization
Rate of unplanned use of non-invasive ventilation or high flow nasal oxygen
Time frame: Within 28 days after randomization
Number of days from randomization until successful extubation
Time frame: Within 28 days after randomization
Total number of days of invasive mechanical ventilation from intubation until successful extubation
Time frame: Within 28 days after randomization
Number of days without the ventilator and alive from randomization until Day 28
Time frame: Within 28 days after randomization
Ventilator acquired pneumonia will be defined by quantitative distal bronchoalveolar lavage cultures growing ≥104cfu/mL
Time frame: Within 28 days after randomization
Number of days in the ICU and in the hospital
Time frame: Within 28 days after randomization
Proportion of patients who died in the ICU and in the hospital
Time frame: Within 28 days after randomization
Rate of patients who died at day 28 after randomization
Time frame: Within 28 days after randomization
Probability of being successfully extubated from randomization until day 28
Time frame: Within 28 days after randomization
The time between randomization and the onset of the SBT, minutes
Time frame: Within 28 days after randomization
Open
Time frame: Within 28 days after randomization
Time between extubation decision and extubation, minutes
Contact information is provided by the study sponsor or research team.
Assistance Publique - Hôpitaux de Paris
Other
Acronym: T-REX
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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