Acute Respiratory Distress Syndrome in ChildrenAOP-KIDNCT07262541
Assessment of Airway Opening Pressure in Invasively Ventilated Children
A study testing Measurement of airway opening pressure in people with Acute Respiratory Distress Syndrome in Children, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome in Children
- What is being tested?
- Measurement of airway opening pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2026to Feb 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Necker-Enfants Malades
Paris, 75015
Charlotte Collignon, MD, 003344495890, charlotte.collignon@aphp.fr
Meryl Vedrenne-Cloquet, M.D., 003344495890, meryl.vedrenne@aphp.fr
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.
Read the 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.
- Being tested
- Measurement of airway opening pressure
- Keywords
- Acute respiratory distress syndrome, Invasively ventilated children, Airway opening pressure (AOP) detection, Children
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of airway opening pressureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Measurement of airway opening pressure with pediatric slow flow method on first | Experimental | 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. Receives: Other: Measurement of airway opening pressure |
| Measurement of airway opening pressure with fixed flow method on first | Experimental | 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. Receives: Other: Measurement of airway opening pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (5)
Prevalence of airway opening pressure
Estimation of the prevalence of airway opening pressure during pediatric acute respiratory distress syndrome.
Measured: 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
Measured: 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
Measured: 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).
Measured: 5 years
Duration of the methods
Duration of each method
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start2 Feb 2026
- Primary completionFeb 2031 (estimated)
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress Syndrome in ChildrenStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Charlotte Collignon, M.D., Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262541
- Sponsor's protocol ID
- APHP250763
- Other IDs
- ID-RCB Number : 2025-A01008-41
- Acronym
- AOP-KID
- Status last verified
- Jun 2026
- First submitted
- 17 Nov 2025
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 37420282Rodriguez 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.
PubMed 38379913
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Airway Opening Pressure in Invasively Ventilated Children
- ClinicalTrials.gov ID
- NCT07262541
- Acronym / sponsor ID
- AOP-KID / APHP250763
- Keywords
- Acute respiratory distress syndrome, Invasively ventilated children, Airway opening pressure (AOP) detection, Children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- Feb 2031 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Measurement of airway opening pressure with pediatric slow flow method on first | Experimental | Other: Measurement of airway opening pressureMeasurement of airway opening pressure in invasively ventilated pediatric patients with "pediatric slow flow method" on first and "fixed flow method" in a second time. |
| Measurement of airway opening pressure with fixed flow method on first | Experimental | Other: Measurement of airway opening pressureMeasurement of airway opening pressure in invasively ventilated pediatric patients with "fixed flow method" on first and "pediatric slow flow method" in a second time. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of airway opening pressureMeasurement 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. | Other | Measurement of airway opening pressure with fixed flow method on first, Measurement of airway opening pressure with pediatric slow flow method on first |
Primary outcome
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.
5 secondary outcomes
Prevalence of airway opening pressure
Time frame: 5 years
Value of airway opening pressure with each of the two measurement methods
Time frame: 1 day
Value of Positive end-expiratory pressure settled by the clinican and measured airway opening pressure
Time frame: 1 day
Description of the tolerance of the two methods of measuring airway opening pressure
Time frame: 5 years
Duration of the methods
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Background: PubMed 37420282Haudebourg 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.
- Background: PubMed 38379913Rodriguez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charlotte Collignon, M.D. principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement of airway opening pressure in people with Acute Respiratory Distress Syndrome in Children, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte COLLIGNON, MD (00330144495890, charlotte.collignon@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the two methods of measuring airway opening pressure (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07262541, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.