Measuring airway opening pressure in invasively ventilated children
Official title: Assessment of Airway Opening Pressure in Invasively Ventilated Children
Run by Assistance Publique - Hôpitaux de Paris · NCT07262541 · Data updated 2026-11-12
This project tries two methods to measure airway opening pressure in children on invasive mechanical ventilation to see if the measurements are feasible.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 17 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | February 2, 2026 |
| Main results expected | February 2031 |
| Study ends | February 2031 |
| Registry record updated | June 30, 2026 |
| Trial ID | NCT07262541 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children older than one year (and ≥10 kg) with ARDS who are invasively and fully passively ventilated in the pediatric ICU and whose guardians provide consent.
✕Probably not a fit
Infants under one year or under 10 kg, patients who are spontaneously breathing, those with very low flow or very high airway resistance that prevent interpretable maneuvers, or patients treated outside the enrolling center are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The study tests two methods for detecting airway opening pressure (AOP) in invasively ventilated pediatric patients: a pediatric slow flow method based on recent bench work and a fixed flow method derived from adult protocols, with the two methods separated by a washout. Air flow will be recorded using a pneumotachograph connected to a T-piece and measurements will be performed while the patient is fully passively ventilated. Feasibility is defined as obtaining at least one interpretable measurement out of three attempts. The trial enrolls children older than one year (and ≥10 kg) in the pediatric ICU meeting PALICC-2 criteria for ARDS at Hôpital Necker-Enfants Malades with parental consent.
Why it matters
Potential benefit: If successful, the methods could help clinicians tailor ventilation to each child's respiratory mechanics and potentially reduce ventilator-related harm.
How similar studies have gone: Related fixed-flow techniques have been used and reported in adults and pediatric bench studies exist, but AOP measurement has not been validated in invasively ventilated children clinically.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Hôpital Necker-Enfants Malades
Paris, France Recruiting
Study contacts
- Principal investigator: Charlotte Collignon, M.D. — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Charlotte COLLIGNON, MD
- Email: charlotte.collignon@aphp.fr
- Phone: 00330144495890
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.