Study of High-flow Oxygen Therapy Against Standard Therapy in Bronchiolitis (Hi-Flo)
|Bronchiolitis||Procedure: High Flow Nasal Cannula Oxygen Therapy Other: Standard low flow oxygen|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Prospective Open Randomized Clinical Trial Comparing High Flow Nasal Cannula Oxygen Therapy Against Standard Therapy for Children Hospitalized With Bronchiolitis|
- Length of hospital stay [ Time Frame: Expected average length of stay 5 days ]Number of hours that the patient remains in hospital.
- Admission to Intensive Care Unit [ Time Frame: During hospitalisation for bronchiolitis, expected average 5 days ]Yes or No
- Work of breathing [ Time Frame: During hospital stay, expected average 5 days ]Work of breathing, assessed by respiratory rate, at four timepoints on day one, and daily thereafter
|Study Start Date:||December 2011|
|Study Completion Date:||December 2014|
|Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Control
Standard low-flow oxygen therapy.
Other: Standard low flow oxygen
Standard low flow oxygen will be given to patients to maintain saturations greater than 92%.
High Flow Nasal Cannula Oxygen Therapy
Procedure: High Flow Nasal Cannula Oxygen Therapy
Warm humidified oxygen will be delivered at 8 liters/minute via nasal cannulae, at a concentration that maintains saturations greater than 92%.
Other Name: High flow oxygen therapy
We propose a prospective open randomised controlled trial to compare high flow nasal cannula oxygen therapy (HFNOT) with standard oxygen therapy for infants hospitalised with bronchiolitis. This study will be the first of its kind, as currently there is no evidence in the published literature.
All children will be cared for by the same medical team on two wards. All aspects of care other than oxygen delivery will not be specified, and be at the discretion of the physicians. HFNOT will not be used as an escalation of care on the wards.
Randomisation will be performed by REDcap, in blocks of 6 patients. Patients will be identified in Emergency, informed consent obtained, and treatment started prior to transfer to the ward.
For patients randomised to HFNOT, the flow rate will be fixed at 8 liters/minute, and the inspired oxygen concentration titrated to maintain saturations above 92%.
Interim statistical analysis will be conducted to determine any positive or negative effect of HFNOT therapy. The first interval analysis will be performed after 50 subjects, the second after 100 subjects. If an effect is found, the study will be terminated following discussion with the hospital statistician and ethics board. Whichever treatment arm is found to be beneficial will be instituted as standard care for children with bronchiolitis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01498094
|Canada, British Columbia|
|British Columbia Children's Hospital|
|Vancouver, British Columbia, Canada, V6H 3N1|
|Principal Investigator:||David Wensley, MD||British Columbia Children's Hospital|