Assessment of Airway Opening Pressure in Invasively Ventilated Children

Recruiting now · Not applicable

Conditions studied: Acute Respiratory Distress Syndrome in Children

In brief

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.

Key facts

Study ID

NCT07262541

Run by

Assistance Publique - Hôpitaux de Paris

People needed

50

Starts

2026-02-02

Expected to finish

2031-02-01

Last updated by the study team

2026-06-30

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Hôpital Necker-Enfants Malades — Paris, France (enrolling)

Full record on ClinicalTrials.gov

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