Impact of Oximetry on Hospitalization in Acute Bronchiolitis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00673946|
Recruitment Status : Completed
First Posted : May 7, 2008
Last Update Posted : December 9, 2013
|Condition or disease||Intervention/treatment||Phase|
|Bronchiolitis||Other: True saturation values displayed Other: Altered saturation values displayed.||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||213 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Impact of Oximetry on Hospitalization|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00673946
|The Hospital for Sick Children|
|Toronto, Ontario, Canada|
|Principal Investigator:||Suzanne Schuh, MD||The Hospital for Sick Children|