NCT07262541 Assessment of Airway Opening Pressure in Invasively Ventilated Children
| NCT ID | NCT07262541 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Acute Respiratory Distress Syndrome in Children |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-02-02 |
| Primary Completion | 2031-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2026-02-02 with a primary completion date of 2031-02.
⚠ 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
Acute respiratory distress syndrome (ARDS) in children is associated with significant morbidity and mortality. Current studies seek to individualize the management of children by defining several phenotypes, based until now mainly on clinical presentation. A better understanding of the respiratory mechanics of each patient could allow the individualization of other phenotypes and adapt their management with individualized ventilation. The method for detecting airway opening pressure (AOP) in children has not yet been validated and the reference methods in adults are difficult to apply in children due to their physiological particularities. The main objective of the study is to evaluate the feasibility of two methods for measuring airway opening pressure in invasively ventilated pediatric patients.
Eligibility Criteria
Inclusion Criteria: * Minor patients weighing more than 5 kg, hospitalized in the pediatric intensive care unit at Necker-Enfants Malades Hospital and receiving invasive ventilation. To assess patients with acute respiratory distress syndrome, the PALICC-2 criteria are used. * Holders of parental authority must be informed and consent to their child's participation in the study. * The patient must be passively ventilated to ensure reliable measurements. This means that the patient must not be spontaneously ventilating and must be completely passively ventilated by the ventilator (no respiratory effort during long-term inflation). Exclusion Criteria: * Respiratory mechanics preventing interpretation of maneuvers (flow too low and/or resistance too high) * Patient \< 5 kg * Refusal by those with parental authority * Patient not affiliated with social security * Patient receiving AME (Medical Aid for Life) * Contraindication or impossibility of performing static respiratory mechanics measurements: pneumothorax or pleural leak, head trauma or threatening HTIC, unstable patient with SpO2 \< 88%, patient receiving nitric oxide (NO) (circuit leaks) or other circuit leaks or patient leaks \> 20% displayed on the ventilator
Contact & Investigator
Charlotte Collignon, M.D.
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT07262541 clinical trial?
This trial is open to participants of all sexes, up to 17 Years, studying Acute Respiratory Distress Syndrome in Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07262541 currently recruiting?
Yes, NCT07262541 is actively recruiting participants. Contact the research team at charlotte.collignon@aphp.fr for enrollment information.
Where is the NCT07262541 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT07262541 clinical trial?
NCT07262541 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Charlotte Collignon, M.D. at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 50 participants.