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Impact of Oximetry on Hospitalization in Acute Bronchiolitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00673946
Recruitment Status : Completed
First Posted : May 7, 2008
Last Update Posted : December 9, 2013
Sponsor:
Information provided by (Responsible Party):
Suzanne Schuh, The Hospital for Sick Children

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bronchiolitis Other: True saturation values displayed Other: Altered saturation values displayed. Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 213 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Impact of Oximetry on Hospitalization
Study Start Date : March 2008
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
In this arm, patients are monitored with oximeters displaying true saturation values
 Other: True saturation values displayed
Physicians will be presented with real saturations.
Experimental: 2
In this arm, patients are monitored with oximeters with displayed saturations 3 percentage points above true values
 Other: Altered saturation values displayed.
Physicians will be presented with saturation measurements three percentage points above the true values.


Outcome Measures
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Primary Outcome Measures :
  1. Hospitalization for bronchiolitis [ Time Frame: 72 hours from start of study ]

Secondary Outcome Measures :
  1. The proportions of infants receiving supplemental oxygen in the ED [ Time Frame: 72 hours from start the study ]
  2. Length of stay in the ED (from the time of arrival to the disposition decision) [ Time Frame: Determined by outcome measure ]
  3. Proportions of infants with unscheduled medical visits for bronchiolitis symptoms to any medical facility [ Time Frame: 72 hours from start of study. ]
  4. Proportion of the ED staff/fellows in "strong agreement" or "agreement" with discharge [ Time Frame: 0, 60, 120, 180, 240, 300, and 360 minutes ]

Eligibility Criteria
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Ages Eligible for Study:   6 Weeks to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00673946


Locations
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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Suzanne Schuh, MD The Hospital for Sick Children
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Suzanne Schuh, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00673946    
Other Study ID Numbers: 1000011675
First Posted: May 7, 2008    Key Record Dates
Last Update Posted: December 9, 2013
Last Verified: December 2013
Keywords provided by Suzanne Schuh, The Hospital for Sick Children:
bronchiolitis
hospitalization
oximetry
pediatrics
Additional relevant MeSH terms:
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Bronchiolitis
Bronchitis
Respiratory Tract Infections
Infections
 Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases