Oxygen Saturation Monitoring in Bronchiolitis
Condition: Bronchiolitis
MeSH terms: Bronchiolitis
Study type: Interventional

Summary: 
      The investigators will conduct a study around the best way to monitor infants hospitalized
      with bronchiolitis, the most common lung infection and a leading reason for hospitalization
      in infants. Infants with bronchiolitis have breathing difficulties and are provided
      supplemental oxygen if their oxygen levels are low. However, there is uncertainty regarding
      how to best monitor oxygen levels. A probe placed on the hand or foot can be used to monitor
      oxygen levels all the time (continuous oxygen monitoring) or just every 4-6 hours
      (intermittent oxygen monitoring). Research has suggested that placing infants with
      bronchiolitis on continuous monitoring results in unnecessary use of oxygen and infants
      staying longer in hospital. However, due to the lack of high quality research, its unclear
      which strategy is best and practice varies. The objective of this study is to conduct high
      quality research across hospitals to determine whether intermittent compared to continuous
      oxygen monitoring will reduce the length of hospital stay in infants hospitalized with
      bronchiolitis. The investigators will also compare safety and cost. The results of this study
      will inform bronchiolitis practice standards and the best use of health care resources.
    

Detailed description: 
      BACKGROUND This research protocol focuses on bronchiolitis, a leading cause of infant
      hospitalization and cumulative expense for the health care system. Supportive management,
      such as oxygen supplementation and monitoring, is the major focus of care, as active medical
      treatment is not effective. Oxygen saturation monitoring may be performed on an intermittent
      (e.g. every 4-6hrs) or continuous basis for stable infants hospitalized with bronchiolitis.
      Observational studies find that the use of continuous monitoring is associated with overuse
      of supplemental oxygen and longer hospital stay. Based on this low quality evidence, practice
      guidelines state that clinicians may choose not to use continuous monitoring and practice
      variation exists due to a lack of RCTs.

      SPECIFIC AIMS Primary: To determine if intermittent vs continuous oxygen saturation
      monitoring will reduce length of hospital stay in infants with bronchiolitis. Secondary: To
      determine differences in other outcomes - effectiveness, safety, acceptability, and cost.

      METHODOLOGY Design: multi-centre, pragmatic, parallel group, 1:1, two arm superiority RCT.
      Population: Previously healthy infants (4 weeks-2 years) hospitalized with bronchiolitis who
      are clinically stable, will be recruited from children's and community hospitals in Ontario,
      Canada.

      Interventions: Randomization to intermittent (every 4hrs) or continuous oxygen saturation
      monitoring. In keeping with local and national clinical practice guidelines, an acceptable
      oxygen saturation target of ≥ 90% will be used for both groups.
    

Intervention name(s): Intermittent oxygen monitoring; Continuous oxygen monitoring
Intervention type(s): Other; Other
Intervention description(s): Oxygen saturation and vital signs will be measured intermittently at a frequency of every 4 hours by the bedside nurse through the child's hospital stay until discharge. Vital signs will be completed every 4 hours.; Oxygen saturation will be measured continuously through the child's hospital stay until discharge. Vital signs will be completed every 4 hours.
Other intervention name(s): Intermittent; Continuous
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Bronchiolitis; Length of Hospital Stay; Clinical Trial; Oxygen Saturation Monitoring