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| ID | Type | Description | Link |
|---|---|---|---|
| ID-RCB Number : 2025-A01008-41 | Other Identifier | Agence nationale de sécurité du médicament et des produits de santé, France |
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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charlotte COLLIGNON, MD | Contact | 00330144495890 | charlotte.collignon@aphp.fr | |
| Hélène Morel | Contact | 0033171196346 | helene.morel@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Charlotte Collignon, M.D. | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Necker-Enfants Malades | Recruiting | Paris | 75015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37420282 | Background | 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. | |
| 38379913 | Background |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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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 |
| 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. |