Impact of Oximetry on Hospitalization in Acute Bronchiolitis

NCT00673946 | Completed Phase 4 DMC

• 1 other identifier: 1000011675
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiolitis

Keywords

bronchiolitis; hospitalization; oximetry; pediatrics

Outcome Measures

Primary Outcomes (1)

• Hospitalization for bronchiolitis

  72 hours from start of study

Secondary Outcomes (4)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

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

Other: True saturation values displayed

2

EXPERIMENTAL

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

Other: Altered saturation values displayed.

Interventions

True saturation values displayed OTHER

Physicians will be presented with real saturations.

1

Altered saturation values displayed. OTHER

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

2

Eligibility Criteria

• Age: 6 Weeks - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Acute bronchiolitis
• Age 4 weeks to 12 months
• Baseline Respiratory Disease Assessment Instrument (RDAI) ≥ 3 points
• Informed consent
• Availability of a telephone

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

Related Publications (1)

• 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.

  PMID: 25138332 DERIVED

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Suzanne Schuh, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: May 5, 2008
• First Posted: May 7, 2008
• Study Start: March 1, 2008
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: December 9, 2013

Record last verified: 2013-12

Locations

CA (1)