Ventilator Settings for Bronchoscopy During Mechanical Ventilation: a Randomized Controlled Study (NCT06562725) | Clinical Trial Compass
CompletedNot Applicable
Ventilator Settings for Bronchoscopy During Mechanical Ventilation: a Randomized Controlled Study
France46 participantsStarted 2024-09-10
Plain-language summary
Fiberoptic bronchoscopy (FOB) can cause a significant increase in respiratory resistances and airway pressure during mechanical ventilation (MV), which can jeopardize the delivery of the ventilatory assistance. This randomized controlled study tests the hypothesis that new ventilator settings aimed at reducing airway pressure may facilitate FOB during MV. Results of this trial should lead to propose a new ventilatory strategy for critically ill patients needing a FOB procedure under MV.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥18 years;
* Acute respiratory failure requiring invasive mechanical ventilation in the intensive care unit;
* Indication of either a fiberoptic bronchoscopy (FOB) procedure or a percutaneous tracheostomy under FOB control;
* Patient under sedation with Richmond Agitation and Sedation Scale(RASS) ≤-2,
* Written informed consent obtained by the patient or the patient legal representative
Exclusion Criteria:
* Presence of an absolute contraindication to FOB (respiratory arrest, severe acute respiratory distress syndrome (ARDS), refractory shock, uncontrolled heart rhythm disorder);
* Patients in respiratory distress or with severe patient-ventilator desynchronies ;
* Patients refusing FOB;
* Pregnancy ;
* Moribund patients (according to American Society of Anesthesiologists (ASA) Physical status score classification, class 5: high probability of death within 24 hours) or at high risk of death during the FOB procedure;
* Patients deprived of liberty;
* Patients under curators or guardianship.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine if the use of specific ventilator settings facilitates the performance of fiberoptic bronchoscopy (FOB) during mechanical ventilation compared to conventional ventilator settings.
Timeframe: 5 minutes after bronchoscopy initiation