Comparison of High Flow Oxygenation Therapy and CPAP in Children With Bronchiolitis.

Esbjerg Hospital - University Hospital of Southern Denmark50 enrolled

Overview

Bronchiolitis in infants and young children often requires respiraty support. In Denmark Continous Positive Airway Pressure ( CPAP) are routinely used in children with moderate-severe bronchiolitis. The aim of the study is to compare CPAP and High Flow Oxygenation Therapy (HFOT) as tools of respiratory support in infants and young children with bronchiolitis. Infants and young children with moderate-severe bronchiolitis and are randomized to either CPAP or HFOT.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Respiratory Syncytial Virus Bronchiolitis

Interventions

Optiflow JuniorDEVICE

Humified air are dispensed through the system. Airflow, FiO2 (Fraction of inspired oxygen) , SpO2 (peripheral capillary Oxygen saturation) and respiratory rate are noted each hour. Progression of condition might lead to change of system og mechanical ventilation. poor tolerance might lead to change of system

Continous Positive Airway PressureDEVICE

Humified air are dispensed throug the system. Airflow, FiO2, SpO2 and respiratory rate are noted each hour. Progression of condition might lead to change of system or mechanical ventilation. Poor tolerance might lead to change of system.

Eligibility

Sex: ALLMin age: 1 DayMax age: 24 Months

Medical Language ↔ Plain English

Inclusion Criteria: * infants and children with moderate respiratoric syncytial virus bronchiolitis or other viral bronchiolitis and need of respiratory support. ( clinical decision) Exclusion Criteria: * severe bronchiolitis with P C02 \> 9, decreased consciusness and risk for early progression to intensive therapy.

Locations (2)

Hospital Lillebaelt

Kolding, Denmark

Signe Vahlkvist

Kolding, Denmark

Outcomes

Primary Outcomes

respiration rate

change in respiration rate ( RR) from preintervention value

Time frame: after 6 12 18 24 and 48 hour of intervention

PCo2

Change in PCo2 (partial pressure of carbon dioxide)from pre intervention value

Time frame: after 6 12 24 and 48 hours of intervention

Modified asthma score (MWAS)

Change in MWAS from pre intervention value

Time frame: Once daily as long as intervention precedes ( 1-14 days)

Secondary Outcomes

treatment length

duration of need of intervention ( hours)

Time frame: from beginning of intervention to discontinuation (1-14 days)

Hspitalization

duration of hospitalisation ( days)

Time frame: from hospitalization to release (1-21 days)

Intervention failure.

numbers of intervention failure defined as change of intervention or progression to need for intensive care/ mechanical ventilation.

Time frame: from beginning of intervention to discontinuation.(1-14 days)

patient acceptance of intervention

VAS score of tolerance with intervention. 0 = worst possible acceptance 5 = fully acceptance

Time frame: daily VAS score (0-5) from beginning of intervention to discontinuation (1-14 days)

Data from ClinicalTrials.gov

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