Impact of Oximetry on Hospitalization in Acute Bronchiolitis

Bronchiolitis Clinical Trial

Official title:

Impact of Oximetry on Hospitalization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00673946
• Other study ID #: 1000011675
• Status: Completed
• Phase: Phase 4
• First received: May 5, 2008
• Last updated: December 6, 2013
• Start date: March 2008
• Est. completion date: May 2013

Study information

• Verified date: December 2013
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Weeks to 12 Months

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

Other:
• True saturation values displayed
Physicians will be presented with real saturations.
• Altered saturation values displayed.
Physicians will be presented with saturation measurements three percentage points above the true values.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalization for bronchiolitis		72 hours from start of study	No
Secondary	The proportions of infants receiving supplemental oxygen in the ED		72 hours from start the study	No
Secondary	Length of stay in the ED (from the time of arrival to the disposition decision)		Determined by outcome measure	No
Secondary	Proportions of infants with unscheduled medical visits for bronchiolitis symptoms to any medical facility		72 hours from start of study.	No
Secondary	Proportion of the ED staff/fellows in "strong agreement" or "agreement" with discharge		0, 60, 120, 180, 240, 300, and 360 minutes	No