Study of High-flow Oxygen Therapy Against Standard Therapy in Bronchiolitis (Hi-Flo)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01498094
Recruitment Status : Completed
First Posted : December 23, 2011
Last Update Posted : May 12, 2015
Information provided by (Responsible Party):
University of British Columbia

December 16, 2011
December 23, 2011
May 12, 2015
December 2011
July 2014   (Final data collection date for primary outcome measure)
Length of hospital stay [ Time Frame: Expected average length of stay 5 days ]
Number of hours that the patient remains in hospital.
Same as current
Complete list of historical versions of study NCT01498094 on Archive Site
  • 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
Same as current
Not Provided
Not Provided
Study of High-flow Oxygen Therapy Against Standard Therapy in Bronchiolitis
A Prospective Open Randomized Clinical Trial Comparing High Flow Nasal Cannula Oxygen Therapy Against Standard Therapy for Children Hospitalized With Bronchiolitis
Bronchiolitis is a common illness of the respiratory tract caused by infection of the tiny airways within the lungs called bronchioles. At present the standard care of hospitalized children with bronchiolitis is oxygen via nasal prongs. In this study the investigators would like to compare standard ward management with a new method of delivering oxygen called high flow nasal cannula oxygen therapy (HFNOT). HFNOT involves breathing warmed, moistened oxygen through nasal cannulae at a flow rate of 8 liters/minute. Accumulated experience suggests that HFNOT eases the child's work of breathing and reduces need for ICU admission and invasive respiratory support.

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.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • 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
  • Other: Standard low flow oxygen
    Standard low flow oxygen will be given to patients to maintain saturations greater than 92%.
  • Active Comparator: Control
    Standard low-flow oxygen therapy.
    Intervention: Other: Standard low flow oxygen
  • Experimental: Intervention
    High Flow Nasal Cannula Oxygen Therapy
    Intervention: Procedure: High Flow Nasal Cannula Oxygen Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2014
July 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • All children under 18 months of age with a clinical diagnosis of bronchiolitis requiring admission to hospital for observation and oxygen.

Exclusion Criteria:

  • Infants admitted directly to ICU from Emergency.
  • Prior positive pressure home ventilation.
  • Tracheostomy.
  • Nasogastric tubes in situ on admission.
  • Upper airway abnormality.
  • Congenital heart disease.
Sexes Eligible for Study: All
up to 18 Months   (Child)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
University of British Columbia
University of British Columbia
Not Provided
Principal Investigator: David Wensley, MD British Columbia Children's Hospital
University of British Columbia
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP