Impact of Oximetry on Hospitalization in Acute Bronchiolitis

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Impact of Oximetry on Hospitalization

Conditions
-----------------
Bronchiolitis

Intervention / Treatment
-----------------
* Other: True saturation values displayed
* Other: Altered saturation values displayed.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute bronchiolitis Age 4 weeks to 12 months Baseline Respiratory Disease Assessment Instrument (RDAI) ≥ 3 points Informed consent Availability of a telephone Exclusion Criteria: Pre-existing pulmonary or cardiac distress, neuromuscular disease, congenital or acquired airway anomalies, hemoglobinopathies, or chronic hypoxia Severe respiratory distress, defined as the retraction component on the RDAI as 8 out of possible 9 points True baseline oxygen saturation less than 88% in room air Transfers from other institutions

Ages Eligible for Study
-----------------
Minimum Age: 6 Weeks
Maximum Age: 12 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>In this arm, patients are monitored with oximeters displaying true saturation values | Other: True saturation values displayed<br>* Physicians will be presented with real saturations.<br>|
| Experimental: 2<br>In this arm, patients are monitored with oximeters with displayed saturations 3 percentage points above true values | Other: Altered saturation values displayed.<br>* Physicians will be presented with saturation measurements three percentage points above the true values.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization for bronchiolitis |  | 72 hours from start of study | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bronchiolitis, hospitalization, oximetry, pediatrics