Intermittent versus continuous oxygen saturation monitoring for infants hospitalised with bronchiolitis: study protocol for a pragmatic randomised controlled trial.

introductionBronchiolitis is the most common reason for hospitalisation in infants in developed countries. The main focus of hospital care is on supportive care, such as monitoring for hypoxia and supplemental oxygen administration, as active therapies lack effectiveness. Pulse oximetry is used to monitor hypoxia in hospitalised infants and is used either intermittently or continuously. Observational studies have suggested that continuous pulse oximetry use leads to a longer length of hospital stay in stable infants. The use of continuous pulse oximetry may lead to unnecessary clinical intervention due to readings that are of little clinical significance, false-positive readings and less reliance on the clinical status. There is a lack of high-quality evidence to guide which pulse oximetry monitoring strategy, intermittent or continuous, is superior in infants hospitalised with bronchiolitis with respect to patient and policy-relevant outcomes. METHODS AND ANALYSIS: This is a multicentre, pragmatic randomised controlled trial comparing two strategies for pulse oximetry monitoring in infants hospitalised for bronchiolitis. Infants aged 1 month to 2 years presenting to Canadian tertiary and community hospitals will be randomised after stabilisation to receive either intermittent or continuous oxygen saturation monitoring on the inpatient unit until discharge. The primary outcome is length of hospital stay. Secondary outcomes include additional measures of effectiveness, acceptability, safety and cost. We will need to enrol 210 infants in order to detect a 12-hour difference in length of stay with a type 1 error rate of 5% and a power of 90%. ETHICS AND DISSEMINATION: Research ethics approval has been obtained for this trial. This trial will provide data to guide hospitals and clinicians on the optimal pulse oximetry monitoring strategy in infants hospitalised with bronchiolitis. We will disseminate the findings of this study through peer-reviewed publication, professional societies and meetings. TRIAL REGISTRATION NUMBER: NCT02947204.