An interventional study of Intermittent oxygen monitoring and Continuous oxygen monitoring in Bronchiolitis, sponsored by The Hospital for Sick Children. Completed at 6 sites in Canada. Open to participants aged 4 Weeks to 24 Months. Per ClinicalTrials.gov, last updated 2020-03-24.
Sponsored by The Hospital for Sick Children · Not applicable, Interventional, and Supportive care
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.
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.
360 studies on the registry are indexed under Bronchiolitis; 43 are open to participants now.
This study's enrollment of 219 is above the median of 80 across 249 interventional studies indexed under Bronchiolitis.
Browse Bronchiolitis studies →The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Children admitted to the general pediatric inpatient unit (GPIU) with bronchiolitis will be eligible if their clinical status is stable and not at high risk of deterioration
Inclusion Criteria:
Exclusion Criteria:
Oxygen saturation will be measured continuously through the child's hospital stay until discharge.
Other: Continuous oxygen monitoring
Oxygen saturation will be measured intermittently, every 4 hours, through the child's hospital stay until discharge.
Other: Intermittent oxygen monitoring
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.
Also known as: Intermittent
Oxygen saturation will be measured continuously through the child's hospital stay until discharge. Vital signs will be completed every 4 hours.
Also known as: Continuous
Length of hospital stay from randomization on the inpatient unit to discharge from hospital
Time frame: 1 month
Duration of oxygen supplementation from randomization to discontinuation of supplementation
Time frame: 1 month
Number of medical interventions performed from time of randomization to hospital discharge
Time frame: 1 month
Time from randomization to meeting hospital discharge criteria
Time frame: 1 month
Length of hospital stay from inpatient unit admission to hospital discharge
Time frame: 1 month
Parent anxiety
Parents will rate their level of anxiety at the current time (state anxiety) and generally (trait anxiety) from the adult State Trait Anxiety Inventory questionnaire during the hospital stay.
Time frame: 1 month
Number of parent work days missed from randomization to 15 days after discharge
Time frame: 15 days after discharge
Nursing satisfaction
The attending nurse will be asked to complete a 10 mm visual analogue scale (VAS) to measure their satisfaction with the quality of monitoring.
Time frame: 1 month
PICU admission after randomization
Time frame: 1 month
PICU consultation after admission
Time frame: 1 month
Unscheduled return to care within 15 days of discharge
Time frame: 15 days after discharge
Mortality
Time frame: 15 days after discharge.
Cost-Effectiveness
Cost-effectiveness will be measured by the incremental cost-effectiveness ratio (ICER), a ratio defined by the incremental difference in costs between treatment arms and the incremental difference in length of stay.
Time frame: 15 days after discharge.
Plan to share: No
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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The Hospital for Sick Children