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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01498094
First received: December 16, 2011
Last updated: September 19, 2012
Last verified: September 2012

December 16, 2011
September 19, 2012
December 2011
May 2013   (final data collection date for primary outcome measure)
Length of hospital stay [ Time Frame: Expected average length of stay 5 days ] [ Designated as safety issue: No ]
Number of hours that the patient remains in hospital.
Same as current
Complete list of historical versions of study NCT01498094 on ClinicalTrials.gov Archive Site
  • Admission to Intensive Care Unit [ Time Frame: During hospitalisation for bronchiolitis, expected average 5 days ] [ Designated as safety issue: No ]
    Yes or No
  • Work of breathing [ Time Frame: During hospital stay, expected average 5 days ] [ Designated as safety issue: No ]
    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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Bronchiolitis
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
May 2013
May 2013   (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.
Both
up to 18 Months
No
Contact: Claire Hathorn, MD 604 875 2119 Claire.Hathorn@cw.bc.ca
Contact: Michael Seear, MD 604 875 2119 mseear@cw.bc.ca
Canada
 
NCT01498094
H11-03032
Yes
University of British Columbia
University of British Columbia
Not Provided
Principal Investigator: David Wensley, MD British Columbia Children's Hospital
University of British Columbia
September 2012

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