NCT05515484 Improvement of Lung and Thoracic Compliance in ARDS Patients in Prone Position by Using Inflatable Air Bag
| NCT ID | NCT05515484 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Centre Hospitalier Universitaire, Amiens |
| Condition | ARDS |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2022-08-23 |
| Primary Completion | 2025-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2022-08-23 with a primary completion date of 2025-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
ARDS is frequent in ICU and may lead to many complications and to death. Prone position is widely used in ADRS patients and demonstrated to decrease mortality. Regarding the chest wall compliance data are missing but the theorical response is that this compliance is decreased in a prone position mainly due to anterior chest and abdomen compression in this position which are more compliant that dorsal part of the body. As well prone position could be associated with complications as pressure ulcers. Because prone position is associated with complications, air bag were developped to decrease pressure on the chest and abdomen and to decrease pressure ulcers. Then, trying to improve chest compliance in prone position and reducing the risk of pressures ulcers could be a challenge with this system in comparison with standard care.
Eligibility Criteria
Inclusion Criteria: * patients with ARDS under mechanical ventilation with P/F ratio\<150 * Age \>18 y/o * Admitted in the medical ICU of Amiens under mechanical ventilation sedated, * With signed informed consent (patient or relative if patient is not conscious) Exclusion Criteria: * patients not eligible for a prone position * Patients with tracheostomy
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05515484 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying ARDS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05515484 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05515484 currently recruiting?
Yes, NCT05515484 is actively recruiting participants. Contact the research team at slama.michel@chu-amiens.fr for enrollment information.
Where is the NCT05515484 trial being conducted?
This trial is being conducted at Amiens, France.
Who is sponsoring the NCT05515484 clinical trial?
NCT05515484 is sponsored by Centre Hospitalier Universitaire, Amiens. The trial plans to enroll 30 participants.