Hôpital Necker-Enfants Malades
Paris, 75015, France
Location status: Recruiting
Location contact
Charlotte Collignon, MD
CONTACT
Meryl Vedrenne-Cloquet, M.D.
CONTACT
NCT Number: NCT07262541
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.
Interested in participating?
Request InfoUp to 17 year
All sexes
Interventional
Not applicable
Paris, 75015, France
Location status: Recruiting
Charlotte Collignon, MD
CONTACT
Meryl Vedrenne-Cloquet, M.D.
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 5 years
Estimation of the prevalence of airway opening pressure during pediatric acute respiratory distress syndrome.
Time frame: 1 day
Value of airway opening pressure with each of the two measurement methods of the study
Time frame: 1 day
Value of Positive end-expiratory pressure settled by the clinican and measured 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).
Time frame: 5 years
Duration of each method
Contact information is provided by the study sponsor or research team.
Charlotte COLLIGNON, MD
CONTACT
Hélène Morel
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
Acronym: AOP-KID
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.
Published trials that share one or more normalized conditions with this study.
NCT03896763
Acute Respiratory Distress Syndrome in Children, Lung Diseases
Birmingham, Alabama, United States
View Trial DetailsNCT06513949
Acute Lung Injury, Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
Seattle, Washington, United States
View Trial DetailsNCT07669558
Acute Respiratory Distress Syndrome (ARDS), Behavior
Shanghai, China
View Trial DetailsNCT07726953
Acute Respiratory Distress Syndrome, Lung Diseases
Beijing, China
View Trial Details