Assessment of Airway Opening Pressure in Invasively Ventilated Children (AOP-KID)

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Respiratory Distress Syndrome in Children
• Intervention / Treatment: Other: Measurement of airway opening pressure

Detailed Description

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: "pediatric slow flow method" based on a recent bench study and "fixed flow method" based on an adult study. The two methods will be separated by a wash out.

The method will be considered feasible if at least one on three measures can be interpretated.

Air flow will be recorded using a pneumotachograph connected to a T piece.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hélène Morel; Phone Number: 0033171196346; Email: helene.morel@aphp.fr
• Study Contact Backup: Name: Charlotte COLLIGNON, MD; Phone Number: 00330144495890; Email: charlotte.collignon@aphp.fr

Study Locations

• France
  • Paris, France, 75015
    • Recruiting
    • Hôpital Necker-Enfants Malades
    • Contact: Charlotte Collignon, MD; Phone Number: 003344495890; Email: charlotte.collignon@aphp.fr
    • Contact: Meryl Vedrenne-Cloquet, M.D.; Phone Number: 003344495890; Email: meryl.vedrenne@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Measurement of airway opening pressure with pediatric slow flow method on first; Measurement of airway opening pressure in invasively ventilated pediatric patients with "pediatric slow flow method" on first and "fixed flow method" in a second time.	Other: 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.
Experimental: Measurement of airway opening pressure with fixed flow method on first; Measurement of airway opening pressure in invasively ventilated pediatric patients with "fixed flow method" on first and "pediatric slow flow method" in a second time.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the two methods of measuring airway opening pressure	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.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of airway opening pressure	Estimation of the prevalence of airway opening pressure during pediatric acute respiratory distress syndrome.	5 years
Value of airway opening pressure with each of the two measurement methods	Value of airway opening pressure with each of the two measurement methods of the study	1 day
Value of Positive end-expiratory pressure settled by the clinican and measured airway opening pressure	Value of Positive end-expiratory pressure settled by the clinican and measured airway opening pressure	1 day
Description of the tolerance of the two methods of measuring airway opening pressure	Description of the tolerance of the two methods of measuring airway opening pressure using the following parameters: minimum SpO2 value (%), variations in heart rate (HR, /min), systolic ans diastolic blood pressure (mmHg), expired CO2 (mmHg).	5 years
Duration of the methods	Duration of each method	5 years

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC-CIC Paris Descartes Necker Cochin
• Investigators: Principal Investigator: Charlotte Collignon, M.D., Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• Haudebourg AF, Moncomble E, Lesimple A, Delamaire F, Louis B, Mekontso Dessap A, Mercat A, Richard JC, Beloncle F, Carteaux G. A novel method for assessment of airway opening pressure without the need for low-flow insufflation. Crit Care. 2023 Jul 7;27(1):273. doi: 10.1186/s13054-023-04560-0.
• Rodriguez Guerineau L, Vieira F, Rodrigues A, Reise K, Todd M, Guerguerian AM, Brochard L. Airway opening pressure maneuver to detect airway closure in mechanically ventilated pediatric patients. Front Pediatr. 2024 Feb 6;12:1310494. doi: 10.3389/fped.2024.1310494. eCollection 2024.

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2026
• Primary Completion (Estimated): February 1, 2031
• Study Completion (Estimated): February 1, 2031

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Actual): December 3, 2025

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Children; Acute respiratory distress syndrome; Invasively ventilated children; Airway opening pressure (AOP) detection
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Respiratory Distress Syndrome
• Other Study ID Numbers: APHP250763; ID-RCB Number : 2025-A01008-41 (Other Identifier: Agence nationale de sécurité du médicament et des produits de santé, France)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No