Impact of Oximetry on Hospitalization in Acute Bronchiolitis
Primary Purpose
Bronchiolitis
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
True saturation values displayed
Altered saturation values displayed.
Sponsored by
About this trial
This is an interventional diagnostic trial for Bronchiolitis focused on measuring bronchiolitis, hospitalization, oximetry, pediatrics
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
Sites / Locations
- The Hospital for Sick Children
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
In this arm, patients are monitored with oximeters displaying true saturation values
In this arm, patients are monitored with oximeters with displayed saturations 3 percentage points above true values
Outcomes
Primary Outcome Measures
Hospitalization for bronchiolitis
Secondary Outcome Measures
The proportions of infants receiving supplemental oxygen in the ED
Length of stay in the ED (from the time of arrival to the disposition decision)
Proportions of infants with unscheduled medical visits for bronchiolitis symptoms to any medical facility
Proportion of the ED staff/fellows in "strong agreement" or "agreement" with discharge
Full Information
NCT ID
NCT00673946
First Posted
May 5, 2008
Last Updated
December 6, 2013
Sponsor
The Hospital for Sick Children
1. Study Identification
Unique Protocol Identification Number
NCT00673946
Brief Title
Impact of Oximetry on Hospitalization in Acute Bronchiolitis
Official Title
Impact of Oximetry on Hospitalization
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
bronchiolitis, hospitalization, oximetry, pediatrics
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
213 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
In this arm, patients are monitored with oximeters displaying true saturation values
Arm Title
2
Arm Type
Experimental
Arm Description
In this arm, patients are monitored with oximeters with displayed saturations 3 percentage points above true values
Intervention Type
Other
Intervention Name(s)
True saturation values displayed
Intervention Description
Physicians will be presented with real saturations.
Intervention Type
Other
Intervention Name(s)
Altered saturation values displayed.
Intervention Description
Physicians will be presented with saturation measurements three percentage points above the true values.
Primary Outcome Measure Information:
Title
Hospitalization for bronchiolitis
Time Frame
72 hours from start of study
Secondary Outcome Measure Information:
Title
The proportions of infants receiving supplemental oxygen in the ED
Time Frame
72 hours from start the study
Title
Length of stay in the ED (from the time of arrival to the disposition decision)
Time Frame
Determined by outcome measure
Title
Proportions of infants with unscheduled medical visits for bronchiolitis symptoms to any medical facility
Time Frame
72 hours from start of study.
Title
Proportion of the ED staff/fellows in "strong agreement" or "agreement" with discharge
Time Frame
0, 60, 120, 180, 240, 300, and 360 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Schuh, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
25138332
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.
Results Reference
derived
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Impact of Oximetry on Hospitalization in Acute Bronchiolitis
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