Measuring airway opening pressure in invasively ventilated children

Assessment of Airway Opening Pressure in Invasively Ventilated Children

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 1 Year to 17 Years
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (Academic / other)
• Locations: 1 site (Paris)
• Trial ID: NCT07262541 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Where this trial is running

Paris

• 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

Conditions Acute Respiratory Distress Syndrome in Children; Acute respiratory distress syndrome; Invasively ventilated children; Airway opening pressure detection; Children