Comparing two methods to improve lung function in patients with brain injuries and ARDS
Alveolar Recruitment Maneuvers, Intracerebral Hemodynamic and Oxygenation
NA · University Hospital, Toulouse · NCT02574169
This study is testing two different breathing techniques to see which one helps improve lung function better in patients with brain injuries and severe breathing problems.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Toulouse (other) |
| Locations | 5 sites (Toulouse, Midi Pyrénées and 4 other locations) |
| Trial ID | NCT02574169 on ClinicalTrials.gov |
What this trial studies
This study compares two different alveolar recruitment maneuvers (ARM) in patients suffering from cerebral injuries and acute respiratory distress syndrome (ARDS). The two methods being evaluated are the extended sigh (eSigh) and continuous positive airway pressure (CPAP). Patients will be randomized to receive each maneuver in a cross-over design, allowing for direct comparison of their efficacy and tolerance. Key parameters such as oxygen tissue partial pressure and hemodynamic data will be collected at various time points to assess the impact of each maneuver.
Who should consider this trial
Good fit: Ideal candidates include patients with brain injuries and moderate to severe ARDS who are currently on mechanical ventilation.
Not a fit: Patients with high intracranial pressure, chronic respiratory diseases, or significant hemodynamic instability may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of lung function in patients with severe brain injuries and ARDS.
How similar studies have performed: While the specific combination of these two approaches is novel, similar studies have shown promise in improving respiratory outcomes in ARDS patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with brain injuries (subarachnoid hemorrhage, traumatic brain injury, ischemic and hemorrhagic stroke) * Patients with moderate and severe ARDS criteria (as defined by classification of Berlin) * Patients under mechanical ventilation Exclusion Criteria: * ICP (Intracranial pressure) \> 25 mmHg * Pregnant women * Patients with history of chronic respiratory disease * Patients with bronchopleural fistula * Patients with hemodynamic instability despite appropriate measures
Where this trial is running
Toulouse, Midi Pyrénées and 4 other locations
- UH Toulouse — Toulouse, Midi Pyrénées, France (RECRUITING)
- UH Caen — Caen, France (RECRUITING)
- UH Clermont-Ferrand — Clermont-Ferrand, France (RECRUITING)
- UH Montpellier — Montpellier, France (RECRUITING)
- UH Nantes — Nantes, France (RECRUITING)
Study contacts
- Principal investigator: Ségolène MROZEK, MD — UH TOULOUSE
- Study coordinator: Ségolène MROZEK, MD
- Email: mrozek.s@chu-toulouse.fr
- Phone: 05 61 77 21 67
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.
Conditions: Cerebral Injuries, Acute Respiratory Distress Syndrome, Alveolar Recruitment Maneuvers, Continuous Positive Airway Pressure, Extended Sigh