Study of High-flow Oxygen Therapy Against Standard Therapy in Bronchiolitis
Hi-Flo
A Prospective Open Randomized Clinical Trial Comparing High Flow Nasal Cannula Oxygen Therapy Against Standard Therapy for Children Hospitalized With Bronchiolitis
1 other identifier
interventional
79
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 16, 2011
CompletedFirst Posted
Study publicly available on registry
December 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedMay 12, 2015
May 1, 2015
2.6 years
December 16, 2011
May 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Length of hospital stay
Number of hours that the patient remains in hospital.
Expected average length of stay 5 days
Secondary Outcomes (2)
Admission to Intensive Care Unit
During hospitalisation for bronchiolitis, expected average 5 days
Work of breathing
During hospital stay, expected average 5 days
Study Arms (2)
Control
ACTIVE COMPARATORStandard low-flow oxygen therapy.
Intervention
EXPERIMENTALHigh Flow Nasal Cannula Oxygen Therapy
Interventions
Warm humidified oxygen will be delivered at 8 liters/minute via nasal cannulae, at a concentration that maintains saturations greater than 92%.
Standard low flow oxygen will be given to patients to maintain saturations greater than 92%.
Eligibility Criteria
You may qualify if:
- All children under 18 months of age with a clinical diagnosis of bronchiolitis requiring admission to hospital for observation and oxygen.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3N1, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Wensley, MD
British Columbia Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2011
First Posted
December 23, 2011
Study Start
December 1, 2011
Primary Completion
July 1, 2014
Study Completion
December 1, 2014
Last Updated
May 12, 2015
Record last verified: 2015-05