Alveolar Recruitment Maneuvers, Intracerebral Hemodynamic and Oxygenation
Stopped: Difficulty with inclusion, demotivation of centers in general
France18 participantsStarted 2016-09-01
Plain-language summary
This study aims to compare 2 alveolar recruitment maneuvers (ARM) in patients with cerebral injuries and acute respiratory distress syndrome (ARDS) in term of efficacy and tolerance.
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:
* 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
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.
1This trial was terminated before completing — can you tell me why it was stopped early, and whether that affects what we know about the safety of alveolar recruitment maneuvers for someone in my situation?
2Since this study was specifically looking at brain oxygen levels (PtiO2) during lung recruitment maneuvers in patients with both brain injury and ARDS, how do you balance the risk of those two conditions affecting each other in my care right now?
3Given that this trial never fully completed and the primary outcome — comparing brain tissue oxygen levels — may not have produced reliable results, what does the current evidence actually say about using recruitment maneuvers safely in patients with cerebral injuries?
4Are there other completed studies or standard-of-care approaches you'd recommend instead of this trial, since it's no longer enrolling and was terminated?
5If managing my lung function with recruitment maneuvers could potentially affect blood flow and oxygen delivery to my brain, what monitoring would be in place to catch any problems early if we pursued a similar approach?
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
Comparison of oxygen tissue partial pressure (PtiO2) values