Study of High-flow Oxygen Therapy Against Standard Therapy in

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Bronchiolitis

Clinical Trial Details

NCT number	NCT01498094
Study type	Interventional
Source	University of British Columbia
Contact
Status	Completed
Phase	N/A
Start date	December 2011
Completion date	December 2014

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms