High Flow Nasal Cannula in Children With Status Asthmaticus

NACompletedINTERVENTIONAL
Enrollment

272

Participants

Timeline

Start Date

August 8, 2018

Primary Completion Date

June 29, 2023

Study Completion Date

June 29, 2023

Conditions
Status Asthmaticus
Interventions
DEVICE

HFNC

"Oxygen therapy will be delivered through high flow nasal cannulas. Aerosol treatments will be administered through a vibrating mesh nebulizer directly connected to the circuit (aerogen®). The airvo® system (Fisher \& Peykel Healthcare, Auckland, New Zealand) will be used as the high flow cannula system in the study. Cannula size will be tailored to the child according to the manufacturer's recommendations. The gas flow will be adjusted according to the child's weight in a predefined chart. FiO2 will be adjusted to allow for a SpO2 \>92%.~All the patients, regardless of their treatment failure status, will be evaluated at H2, H6, H12 and H24 to monitor their evolution (evaluation of the standard parameters, consciousness, PRAM (Pediatric Respiratory Assessment Measure) score, pain assessment by the FLACC (Face Legs Activity Cry Consolability) score). ."

DEVICE

Standard Oxygen Treatment

"Children will receive supplemental oxygen as commonly delivered through a non-rebreather face mask or low flow nasal cannula (standard oxygen treatment) and beta2 agonist aerosol via vibrating mesh nebulizer (aerogen®) according to the procedures usually used in the unit and according to the GINA (Global Initiative for Asthma) protocol. This group is the standard treatment group and is therefore the control group.~All the patients, regardless of their treatment failure status, will be evaluated at H2, H6, H12 and H24 to monitor their evolution (evaluation of the standard parameters, consciousness, PRAM score, pain assessment by the FLACC score). The use of adjuvant therapies (magnesium sulfate, salbutamol IVSE, and ipratropium bromide) will remain at the discretion of the physician in charge of the child and will be evaluated as a secondary criterion."

Trial Locations (14)

Unknown

Hôpital Femme-Mère-Enfant, Bron

CHU de Dijon, Dijon

CHU de Grenoble Alpes, Grenoble

Hôpital Bicêtre, Le Kremlin-Bicêtre

Hôpital Timone 2, Marseille

CH Annecy Genevois, Metz-Tessy

CHU Arnaud de Villeneuve, Montpellier

CHU de Nantes, Nantes

Chu Lenval, Nice

Hôpital Armand Trousseau, Paris

Hôpital Necker Enfants Malades, Paris

Hôpital Robert Debré, Paris

CHU Strasbourg,, Strasbourg

CH Villefranche sur Saône,, Villefranche-sur-Saône

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER

NCT03157102 - High Flow Nasal Cannula in Children With Status Asthmaticus | Biotech Hunter | Biotech Hunter