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

NCT ID: NCT01498094

Last Updated: 2015-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2014-12-31

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.

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.

Conditions

Bronchiolitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Standard low-flow oxygen therapy.

Group Type: ACTIVE_COMPARATOR

Standard low flow oxygen

Intervention Type: OTHER

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

Intervention

High Flow Nasal Cannula Oxygen Therapy

Group Type: EXPERIMENTAL

High Flow Nasal Cannula Oxygen Therapy

Intervention Type: PROCEDURE

Warm humidified oxygen will be delivered at 8 liters/minute via nasal cannulae, at a concentration that maintains saturations greater than 92%.

Interventions

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%.

Intervention Type: PROCEDURE

Standard low flow oxygen

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

Intervention Type: OTHER

Other Intervention Names

High flow oxygen therapy

Eligibility 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.

• Maximum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Wensley, MD

Role: PRINCIPAL_INVESTIGATOR

British Columbia Children's Hospital

Locations

British Columbia Children's Hospital

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H11-03032

Identifier Type: -

Identifier Source: org_study_id