Impact of Oximetry on Hospitalization in Acute Bronchiolitis

NCT ID: NCT00673946

Last Updated: 2013-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 213 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2013-05-31

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.

Conditions

Bronchiolitis

Keywords

bronchiolitis; hospitalization; oximetry; pediatrics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

1

In this arm, patients are monitored with oximeters displaying true saturation values

Group Type: ACTIVE_COMPARATOR

True saturation values displayed

Intervention Type: OTHER

Physicians will be presented with real saturations.

2

In this arm, patients are monitored with oximeters with displayed saturations 3 percentage points above true values

Group Type: EXPERIMENTAL

Altered saturation values displayed.

Intervention Type: OTHER

Physicians will be presented with saturation measurements three percentage points above the true values.

Interventions

True saturation values displayed

Physicians will be presented with real saturations.

Intervention Type: OTHER

Altered saturation values displayed.

Physicians will be presented with saturation measurements three percentage points above the true values.

Intervention Type: OTHER

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

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Suzanne Schuh

Staff Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suzanne Schuh, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 25138332 (View on PubMed)

Other Identifiers

1000011675

Identifier Type: -

Identifier Source: org_study_id