Skip to main content
OpenTrials
Completed

NCT Number: NCT01498094

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bronchiolitis Bronchial Diseases Bronchitis Infections Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

Up to 18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High Flow Nasal Cannula Oxygen Therapy

Procedure

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

Other names: High flow oxygen therapy

Standard low flow oxygen

Other

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

Primary outcomes

  1. Length of hospital stay

    Time frame: Expected average length of stay 5 days

    Number of hours that the patient remains in hospital.

Secondary outcomes

  1. Admission to Intensive Care Unit

    Time frame: During hospitalisation for bronchiolitis, expected average 5 days

    Yes or No

  2. Work of breathing

    Time frame: During hospital stay, expected average 5 days

    Work of breathing, assessed by respiratory rate, at four timepoints on day one, and daily thereafter

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Acronym: Hi-Flo

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Dec 23, 2011
Registry last updated
May 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.