Actively Recruiting

Phase Not Applicable
Age: 1Year - 17Years
All Genders
NCT07262541

Assessment of Airway Opening Pressure in Invasively Ventilated Children

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-02-13

50

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

Sponsors

A

Assistance Publique - Hôpitaux de Paris

Lead Sponsor

U

URC-CIC Paris Descartes Necker Cochin

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Assessment of Airway Opening Pressure in Invasively Ventilated Children

Who Can Participate

Age: 1Year - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Minor patients aged > 1 year hospitalized in the pediatric intensive care unit at Necker-Enfants Malades Hospital and receiving invasive ventilation
  • Patients meeting PALICC-2 criteria for acute respiratory distress syndrome
  • Holders of parental authority must be informed and consent to their child's participation
  • Patients must be passively ventilated without respiratory effort during long-term inflation
Not Eligible

You will not qualify if you...

  • Respiratory mechanics that prevent interpretation of maneuvers due to very low flow or high resistance
  • Patients under 1 year of age or weighing less than 10 kilograms
  • Refusal of consent by those with parental authority
  • Patients not affiliated with social security
  • Patients receiving Medical Aid for Life (AME)
  • Contraindications to static respiratory mechanics measurements such as pneumothorax, pleural leak, head trauma, threatening intracranial hypertension
  • Unstable patients with oxygen saturation below 88%
  • Patients receiving nitric oxide or having circuit leaks greater than 20% displayed on the ventilator

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hôpital Necker-Enfants Malades

Paris, France, 75015

Actively Recruiting

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Research Team

C

Charlotte COLLIGNON, MD

CONTACT

H

Hélène Morel

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

CROSSOVER

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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