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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | In this arm, patients are monitored with oximeters displaying true saturation values |
|
| 2 | Experimental | In this arm, patients are monitored with oximeters with displayed saturations 3 percentage points above true values |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| True saturation values displayed | Other | Physicians will be presented with real saturations. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization for bronchiolitis | 72 hours from start of study |
| Measure | Description | Time Frame |
|---|---|---|
| The proportions of infants receiving supplemental oxygen in the ED | 72 hours from start the study | |
| Length of stay in the ED (from the time of arrival to the disposition decision) | Determined by outcome measure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suzanne Schuh, MD | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25138332 | Derived | Schuh S, Freedman S, Coates A, Allen U, Parkin PC, Stephens D, Ungar W, DaSilva Z, Willan AR. Effect of oximetry on hospitalization in bronchiolitis: a randomized clinical trial. JAMA. 2014 Aug 20;312(7):712-8. doi: 10.1001/jama.2014.8637. |
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| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
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| Altered saturation values displayed. |
| Other |
Physicians will be presented with saturation measurements three percentage points above the true values. |
|
| Proportions of infants with unscheduled medical visits for bronchiolitis symptoms to any medical facility | 72 hours from start of study. |
| Proportion of the ED staff/fellows in "strong agreement" or "agreement" with discharge | 0, 60, 120, 180, 240, 300, and 360 minutes |
| D012140 |
| Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |