Effects of Extravascular Lung Water on Prone Position Efficacy in Patients With ARDS (NCT04635267) | Clinical Trial Compass
UnknownNot Applicable
Effects of Extravascular Lung Water on Prone Position Efficacy in Patients With ARDS
200 participantsStarted 2021-01-01
Plain-language summary
The study will investigate the influence that extravascular lung water index (EVLWi) could have on the efficacy and persistance of efficacy of prone position in patients with acute respiratory distress syndrome.
Prone position will increase blood oxygenation in 75% of the cases and will be persistant in half of the cases. Unfortunately, no clinical criteria has been found correlated with efficacy. The quantity of lung edema, with increased lung weight, could be a determinant factor of efficacy and the persistance of the efficacy. EVLWi, assessed with the PiCCO2 device, reflects the quantity of fluid accumulated in interstitial and alveolar spaces.
The hypothesis is that patients with higher EVLWi will have less efficacy of prone position in oxygenation and also that the beneficial effects of prone position will last shorter compared to patients with lower EVLWi.
Who can participate
Age range
18 Years – 99 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
* Presence of acute respiratory distress syndrome
* Decision to perform prone position according to the physician in charge of the patient
* Hemodynamic monitoring with a PiCCO2 device (Pulsion Medical Systems, Feldkirchen, Allemagne)
Exclusion Criteria:
* Absence of affiliation to the French Sociale security
* Patient under a tutelage measure or placed under judicial protection
* Known pregnancy
* Currently receiving ECMO therapy
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
Correlation between extravascular lung water index (EVLWi) just before prone position (baseline) and the time course of the partial arterial pressure in oxygen over inspired fraction of oxygen (PaO2/FiO2) ratio during prone position.