The Hospital for Sick Children
Toronto, Ontario, Canada
NCT Number: NCT00673946
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.
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Notify Me6 week–12 month
All sexes
Interventional
Phase 4
Toronto, Ontario, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Physicians will be presented with real saturations.
Physicians will be presented with saturation measurements three percentage points above the true values.
Time frame: 72 hours from start of study
Time frame: 72 hours from start the study
Time frame: Determined by outcome measure
Time frame: 72 hours from start of study.
Time frame: 0, 60, 120, 180, 240, 300, and 360 minutes
The Hospital for Sick Children
Other
Impact of Oximetry on Hospitalization
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