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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01498094
First received: December 16, 2011
Last updated: September 25, 2014
Last verified: September 2014
History of Changes
  Purpose

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.


Condition Intervention
Bronchiolitis
 Procedure: High Flow Nasal Cannula Oxygen Therapy
Other: Standard low flow oxygen

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Enrollment: 79
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%.
Experimental: Intervention
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

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   up to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01498094

Locations
Canada, British Columbia
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V6H 3N1
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: David Wensley, MD British Columbia Children's Hospital
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01498094     History of Changes
Other Study ID Numbers: H11-03032
Study First Received: December 16, 2011
Last Updated: September 25, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Bronchiolitis
High
Flow
Oxygen
 Therapy
Nasal
Cannulae
Prongs

Additional relevant MeSH terms:
Bronchiolitis
Bronchial Diseases
Bronchitis
Lung Diseases
 Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on February 27, 2015