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NCT Number: NCT07262541

Assessment of Airway Opening Pressure in Invasively Ventilated Children

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.

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Key information

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Measurement of airway opening pressure

Other

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.

Primary outcomes

  1. Feasibility of the two methods of measuring airway opening pressure

    Time frame: 5 years

    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.

Secondary outcomes

  1. Prevalence of airway opening pressure

    Time frame: 5 years

    Estimation of the prevalence of airway opening pressure during pediatric acute respiratory distress syndrome.

  2. Value of airway opening pressure with each of the two measurement methods

    Time frame: 1 day

    Value of airway opening pressure with each of the two measurement methods of the study

  3. Value of Positive end-expiratory pressure settled by the clinican and measured airway opening pressure

    Time frame: 1 day

    Value of Positive end-expiratory pressure settled by the clinican and measured airway opening pressure

  4. Description of the tolerance of the two methods of measuring airway opening pressure

    Time frame: 5 years

    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. Duration of the methods

    Time frame: 5 years

    Duration of each method

Study contacts

Contact information is provided by the study sponsor or research team.

Charlotte COLLIGNON, MD

CONTACT

[email protected]

00330144495890

Hélène Morel

CONTACT

[email protected]

0033171196346

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: AOP-KID

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Dec 3, 2025
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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