RecruitingNot ApplicableNCT07262541

Assessment of Airway Opening Pressure in Invasively Ventilated Children


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

50 participants

Start Date

Feb 2, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 1 YearMax Age: 17 Years

Inclusion Criteria3

  • Minor patients aged > 1 year 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 Criteria6

  • Respiratory mechanics preventing interpretation of maneuvers (flow too low and/or resistance too high)
  • Patient < 10 kg and/or child under 1 year of age
  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERMeasurement 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.


Locations(1)

Hôpital Necker-Enfants Malades

Paris, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07262541