Impact of Oximetry on Hospitalization in Acute Bronchiolitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Suzanne Schuh, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00673946
First received: May 5, 2008
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Bronchiolitis
Other: True saturation values displayed
Other: Altered saturation values displayed.
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Impact of Oximetry on Hospitalization

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Hospitalization for bronchiolitis [ Time Frame: 72 hours from start of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportions of infants receiving supplemental oxygen in the ED [ Time Frame: 72 hours from start the study ] [ Designated as safety issue: No ]
  • Length of stay in the ED (from the time of arrival to the disposition decision) [ Time Frame: Determined by outcome measure ] [ Designated as safety issue: No ]
  • Proportions of infants with unscheduled medical visits for bronchiolitis symptoms to any medical facility [ Time Frame: 72 hours from start of study. ] [ Designated as safety issue: No ]
  • Proportion of the ED staff/fellows in "strong agreement" or "agreement" with discharge [ Time Frame: 0, 60, 120, 180, 240, 300, and 360 minutes ] [ Designated as safety issue: No ]

Enrollment: 213
Study Start Date: March 2008
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   6 Weeks to 12 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00673946

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Suzanne Schuh, MD The Hospital for Sick Children
  More Information

No publications provided by The Hospital for Sick Children

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Suzanne Schuh, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00673946     History of Changes
Other Study ID Numbers: 1000011675
Study First Received: May 5, 2008
Last Updated: December 6, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
bronchiolitis
hospitalization
oximetry
pediatrics

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on August 26, 2014