Study of High-flow Oxygen Therapy Against Standard Therapy in Bronchiolitis

Bronchiolitis Clinical Trial

— Hi-Flo  

Official title:

A Prospective Open Randomized Clinical Trial Comparing High Flow Nasal Cannula Oxygen Therapy Against Standard Therapy for Children Hospitalized With Bronchiolitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01498094
• Other study ID #: H11-03032
• Status: Completed
• Phase: N/A
• First received: December 16, 2011
• Last updated: May 8, 2015
• Start date: December 2011
• Est. completion date: December 2014

Study information

• Verified date: May 2015
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: December 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Months

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

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:
• Standard low flow oxygen
Standard low flow oxygen will be given to patients to maintain saturations greater than 92%.

Locations

Country	Name	City	State
Canada	British Columbia Children's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospital stay	Number of hours that the patient remains in hospital.	Expected average length of stay 5 days	No
Secondary	Admission to Intensive Care Unit	Yes or No	During hospitalisation for bronchiolitis, expected average 5 days	No
Secondary	Work of breathing	Work of breathing, assessed by respiratory rate, at four timepoints on day one, and daily thereafter	During hospital stay, expected average 5 days	No