A Phase 4 interventional study of True saturation values displayed and Altered saturation values displayed. in Bronchiolitis, sponsored by The Hospital for Sick Children. Completed at 1 site in Canada. Open to participants aged 6 Weeks to 12 Months. Per ClinicalTrials.gov, last updated 2013-12-09.
Sponsored by The Hospital for Sick Children · Phase 4, Interventional, and Diagnostic
To determine, in previously healthy infants 6 weeks to 12 months of age, diagnosed with acute bronchiolitis and monitored by hourly oximetry, if the probability of hospitalization within 72 hours of arrival in those whose oxygen saturation display is manipulated 3 percentage points above the true measurements is significantly lower in comparison to those whose monitors display true saturations.
This is the first bronchiolitis study to examine the clinical and economic impact of making disposition decision on primarily clinical grounds, while blinding the physicians to oxygen saturations by providing them with either true saturation measurements or those which are 3 percentage points above the true values. Although physiologically insignificant and within the measurement error of the instrument, this difference has been shown to be perceived as clinically relevant and to have a major hypothetical impact on disposition, without any evidence to support this belief.
We hope to find out if children with oxygen saturations above or in the vicinity of the threshold recommended for initiation of oxygen therapy by the AAP can be safely discharged based on their clinical appearance rather than to have their hospitalization dictated by a locally defined number. This study will hopefully provide much needed evidence necessary to help us interpret the oximetry results more meaningful which may in turn lead to fewer hospitalizations, shorter length of hospital stay and lower health care costs.
360 studies on the registry are indexed under Bronchiolitis; 43 are open to participants now.
This study's enrollment of 213 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.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In this arm, patients are monitored with oximeters displaying true saturation values
Other: True saturation values displayed
In this arm, patients are monitored with oximeters with displayed saturations 3 percentage points above true values
Other: Altered saturation values displayed.
Physicians will be presented with real saturations.
Physicians will be presented with saturation measurements three percentage points above the true values.
Hospitalization for bronchiolitis
Time frame: 72 hours from start of study
The proportions of infants receiving supplemental oxygen in the ED
Time frame: 72 hours from start the study
Length of stay in the ED (from the time of arrival to the disposition decision)
Time frame: Determined by outcome measure
Proportions of infants with unscheduled medical visits for bronchiolitis symptoms to any medical facility
Time frame: 72 hours from start of study.
Proportion of the ED staff/fellows in "strong agreement" or "agreement" with discharge
Time frame: 0, 60, 120, 180, 240, 300, and 360 minutes
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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The Hospital for Sick Children