Comparison of High Flow Oxygenation Therapy and CPAP in Children With Bronchiolitis.
|ClinicalTrials.gov Identifier: NCT02618213|
Recruitment Status : Recruiting
First Posted : December 1, 2015
Last Update Posted : August 24, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Syncytial Virus Bronchiolitis||Device: Optiflow Junior Device: Continous Positive Airway Pressure||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of High Flow Oxygenation Therapy and CPAP in Children With Bronchiolitis.|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
Active Comparator: Continous Positive Airway Pressure
CPAP is administered through a binasal tube fitted with a Benveniste gas jet administered with humified airflow. Start flow is 12-14 l/min and can be changed to maximum 15 or minimum 12 l/min. Oxygen can be supplied as needed to keep SpO2 (peripheral capillary Oxygen saturation) within acceptable limits.
Device: Continous Positive Airway Pressure
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.
Other Name: CPAP
Active Comparator: High Flow Oxygenation Therapy
HFOT is administered by optiflow Junior ( Fisher&Paykal Healthcare® Auckland, New Zealand) Start flow 12-14 l/min. Oxygen can be supplied as needed to keep Sp02 within acceptable limits
Device: Optiflow Junior
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
- respiration rate [ Time Frame: after 6 12 18 24 and 48 hour of intervention ]change in respiration rate ( RR) from preintervention value
- PCo2 [ Time Frame: after 6 12 24 and 48 hours of intervention ]Change in PCo2 (partial pressure of carbon dioxide)from pre intervention value
- Modified asthma score (MWAS) [ Time Frame: Once daily as long as intervention precedes ( 1-14 days) ]Change in MWAS from pre intervention value
- treatment length [ Time Frame: from beginning of intervention to discontinuation (1-14 days) ]duration of need of intervention ( hours)
- Hspitalization [ Time Frame: from hospitalization to release (1-21 days) ]duration of hospitalisation ( days)
- Intervention failure. [ Time Frame: from beginning of intervention to discontinuation.(1-14 days) ]numbers of intervention failure defined as change of intervention or progression to need for intensive care/ mechanical ventilation.
- patient acceptance of intervention [ Time Frame: daily VAS score (0-5) from beginning of intervention to discontinuation (1-14 days) ]VAS score of tolerance with intervention. 0 = worst possible acceptance 5 = fully acceptance
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02618213
|Contact: Signe Vahlkvist, MD PhD||+4522334666||Signevv@gmail.com|
|Kolding, Denmark, 6000|
|Contact: Signe Vahlkvist, MD Ph.D +4522334666 Signevv@gmail.com|
|Principal Investigator:||Signe VAhlkvist, MD PhD||Pediatric Award, Hospital of South West Denmark|