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Compares treatment options for Weaning From Mechanical Ventilation, Extubation
Official title Direct Extubation Versus Extubation After a Spontaneous Breathing Trial in Patients at Low Risk of Extubation Failure
ClinicalTrials.gov ID: NCT07019636
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Age older than 18 years and \< 65 years old
- Nasal or oral intubation longer than 24 hours and less than 4 days
- Satisfaction to each following weaning readiness criteria:
- Respiratory rate \< 35 cycles per minute
- SpO2 \>90% with FiO2\<40% and PEEP\<8 cmH2O
You likely can't join if
- Risk factor for extubation failure as defined by any of the following criteria:
- Chronic cardiac disease (left ejection fraction below 45%, documented history of cardiogenic pulmonary edema, permanent atrial fibrillation).
- Chronic respiratory disease (severe COPD, documented restricted lung disease or obesity-hypoventilation syndrome)
- Body mass index \> 30 kg/m2
- Airway patency problems, including high risk of developing laryngeal edema, inability to deal with respiratory secretions, brain injury, documented...
- Tracheostomy
See the full eligibility criteria
- Age older than 18 years and \< 65 years old
- Nasal or oral intubation longer than 24 hours and less than 4 days
- Satisfaction to each following weaning readiness criteria:
- Respiratory rate \< 35 cycles per minute
- SpO2 \>90% with FiO2\<40% and PEEP\<8 cmH2O
- RASS score between -2 and +2 with low level or no sedatives
- No need or low doses of vasopressors
- Adequate cough
- Inform consent by patient or legal representative or the close relative or emergency inclusion procedure.
- Risk factor for extubation failure as defined by any of the following criteria:
- Chronic cardiac disease (left ejection fraction below 45%, documented history of cardiogenic pulmonary edema, permanent atrial fibrillation).
- Chronic respiratory disease (severe COPD, documented restricted lung disease or obesity-hypoventilation syndrome)
- Body mass index \> 30 kg/m2
- Airway patency problems, including high risk of developing laryngeal edema, inability to deal with respiratory secretions, brain injury, documented swallowing disorders
- Tracheostomy
- Underlying chronic neuromuscular disease
- Do not resuscitate orders
- Pregnant or lacting woman
- Patient under guardianship
- Patient without healthcare insurance
- Refusal to participate and sign the written consent
- Patients with traumatic brain injury
- Post surgery patients
- Patients included in another treatment trial that may have an impact on the evaluation criteria of the present study
- Patient under AME
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.