Assessment of Airway Opening Pressure in Invasively Ventilated Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 17
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Measurement of airway opening pressure
Other interventionMeasurement 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Measurement of airway opening pressure with pediatric slow flow method on firstExperimental treatment 1 intervention
Group B: Measurement of airway opening pressure with fixed flow method on firstExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
5 yearsSecondary outcomes
1
Prevalence of airway opening pressure
Estimation of the prevalence of airway opening pressure during pediatric acute respiratory distress syndrome.
Time frame
5 years2
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
Time frame
1 day3
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
Time frame
1 day4
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).
Time frame
5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Assistance Publique - Hôpitaux de Paris
Lead sponsor
URC-CIC Paris Descartes Necker Cochin
Collaborator
Source ClinicalTrials.gov