Study of High-flow Oxygen Therapy Against Standard Therapy in Bronchiolitis (Hi-Flo)
|ClinicalTrials.gov Identifier: NCT01498094|
Recruitment Status : Completed
First Posted : December 23, 2011
Last Update Posted : May 12, 2015
|Condition or disease||Intervention/treatment||Phase|
|Bronchiolitis||Procedure: High Flow Nasal Cannula Oxygen Therapy Other: Standard low flow oxygen||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||79 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Open Randomized Clinical Trial Comparing High Flow Nasal Cannula Oxygen Therapy Against Standard Therapy for Children Hospitalized With Bronchiolitis|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||December 2014|
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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|