Ireland
--:--IST
Recruiting Not applicable

Assessment of Airway Opening Pressure in Invasively Ventilated Children

NCT07262541 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-02-02
Last updated
2026-06-30

Condition(s) studied

Acute Respiratory Distress Syndrome in Children

Investigational drug(s) / intervention(s)

Measurement of airway opening pressure

Measurement of airway opening pressure: Measurement of airway opening pressure in invasively ventilated pediatric patients with 2 methods, "fixed flow method" and "pediatric slow flow method". The two methods will be separated by a washout period. The order of the airway opening pressure detection methods will be random.

Study 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

Sex
ALL
Min age
—
Max age
17 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Feasibility of the two methods of measuring airway opening pressure — 5 years
    The method will be considered feasible if at least one maneuver out of three allows a measurement of the airway opening pressure to be obtained.

Trial sites (1)

FacilityCityRegionStatus
Hôpital Necker-Enfants Malades Paris France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07262541 on ClinicalTrials.gov ↗ ← All trials in France