New ventilator settings for bronchoscopy in critically ill patients
Ventilator Settings for Bronchoscopy During Mechanical Ventilation: a Randomized Controlled Study
This study is testing new ventilator settings during bronchoscopy to see if they can make the procedure safer for critically ill patients on mechanical ventilation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Arras Academic / other |
| Locations | 1 site (Arras) |
| Trial ID | NCT06562725 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of new ventilator settings on the safety and effectiveness of fiberoptic bronchoscopy (FOB) in patients undergoing mechanical ventilation. The study aims to reduce airway pressure during the procedure by adjusting inspiratory flow, tidal volume, and other ventilatory parameters. Patients will be randomly assigned to either the new ventilatory strategy or standard settings, with the primary goal of minimizing serious adverse events during FOB. The findings could lead to improved protocols for managing critically ill patients requiring bronchoscopy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are experiencing acute respiratory failure and require invasive mechanical ventilation.
Not a fit: Patients with severe contraindications to bronchoscopy or those in critical condition with a high risk of death may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and efficacy of bronchoscopy procedures in mechanically ventilated patients.
How similar studies have performed: While this approach is novel, similar studies have indicated the importance of optimizing ventilator settings during invasive procedures, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Arras
- Arras Hospital — Arras, France (Recruiting)
Study contacts
- Principal investigator: Malcolm LEMYZE, Dr — arras hospital
- Study coordinator: Kathleen JACQUEZ
- Email: recherche.clinique@gh-artoisternois.fr
- Phone: 0321211599
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.