Impact of Oximetry on Hospitalization in Acute Bronchiolitis
|Bronchiolitis||Other: True saturation values displayed Other: Altered saturation values displayed.||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||Impact of Oximetry on Hospitalization|
- 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 ]
|Study Start Date:||March 2008|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Active Comparator: 1
In this arm, patients are monitored with oximeters displaying true saturation values
Other: True saturation values displayed
Physicians will be presented with real saturations.
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 saturation measurements three percentage points above the true values.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00673946
|The Hospital for Sick Children|
|Toronto, Ontario, Canada|
|Principal Investigator:||Suzanne Schuh, MD||The Hospital for Sick Children|