Clinical trial NCT00673946: Impact of Oximetry on Hospitalization in Acute Bronchiolitis
Official title: Impact of Oximetry on Hospitalization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bronchiolitis
Keywords: bronchiolitis
hospitalization
oximetry
pediatrics
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2008-05-07
Enrollment: 213
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Hospitalization for bronchiolitis
timeFrame: 72 hours from start of study
Secondary outcomes:
measure: The proportions of infants receiving supplemental oxygen in the ED
timeFrame: 72 hours from start the study
measure: Length of stay in the ED (from the time of arrival to the disposition decision)
timeFrame: Determined by outcome measure
measure: Proportions of infants with unscheduled medical visits for bronchiolitis symptoms to any medical facility
timeFrame: 72 hours from start of study.
measure: Proportion of the ED staff/fellows in "strong agreement" or "agreement" with discharge
timeFrame: 0, 60, 120, 180, 240, 300, and 360 minutes
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Suzanne Schuh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.