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Oxygen Saturation Monitoring in 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. Identifier: NCT02947204
Recruitment Status : Completed
First Posted : October 27, 2016
Last Update Posted : March 24, 2020
Canadian Institutes of Health Research (CIHR)
Children's Hospital of Eastern Ontario
Information provided by (Responsible Party):
Sanjay Mahant, The Hospital for Sick Children

Brief Summary:
The investigators will conduct a study around the best way to monitor infants hospitalized with bronchiolitis, the most common lung infection and a leading reason for hospitalization in infants. Infants with bronchiolitis have breathing difficulties and are provided supplemental oxygen if their oxygen levels are low. However, there is uncertainty regarding how to best monitor oxygen levels. A probe placed on the hand or foot can be used to monitor oxygen levels all the time (continuous oxygen monitoring) or just every 4-6 hours (intermittent oxygen monitoring). Research has suggested that placing infants with bronchiolitis on continuous monitoring results in unnecessary use of oxygen and infants staying longer in hospital. However, due to the lack of high quality research, its unclear which strategy is best and practice varies. The objective of this study is to conduct high quality research across hospitals to determine whether intermittent compared to continuous oxygen monitoring will reduce the length of hospital stay in infants hospitalized with bronchiolitis. The investigators will also compare safety and cost. The results of this study will inform bronchiolitis practice standards and the best use of health care resources.

Condition or disease Intervention/treatment Phase
Bronchiolitis Other: Intermittent oxygen monitoring Other: Continuous oxygen monitoring Not Applicable

Detailed Description:

BACKGROUND This research protocol focuses on bronchiolitis, a leading cause of infant hospitalization and cumulative expense for the health care system. Supportive management, such as oxygen supplementation and monitoring, is the major focus of care, as active medical treatment is not effective. Oxygen saturation monitoring may be performed on an intermittent (e.g. every 4-6hrs) or continuous basis for stable infants hospitalized with bronchiolitis. Observational studies find that the use of continuous monitoring is associated with overuse of supplemental oxygen and longer hospital stay. Based on this low quality evidence, practice guidelines state that clinicians may choose not to use continuous monitoring and practice variation exists due to a lack of RCTs.

SPECIFIC AIMS Primary: To determine if intermittent vs continuous oxygen saturation monitoring will reduce length of hospital stay in infants with bronchiolitis. Secondary: To determine differences in other outcomes - effectiveness, safety, acceptability, and cost.

METHODOLOGY Design: multi-centre, pragmatic, parallel group, 1:1, two arm superiority RCT. Population: Previously healthy infants (4 weeks-2 years) hospitalized with bronchiolitis who are clinically stable, will be recruited from children's and community hospitals in Ontario, Canada.

Interventions: Randomization to intermittent (every 4hrs) or continuous oxygen saturation monitoring. In keeping with local and national clinical practice guidelines, an acceptable oxygen saturation target of ≥ 90% will be used for both groups.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 219 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Intermittent vs. Continuous Oxygen Saturation Monitoring in Infants Hospitalized for Bronchiolitis: A Randomized Controlled Trial
Actual Study Start Date : November 2016
Actual Primary Completion Date : May 2019
Actual Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Continuous oxygen monitoring
Oxygen saturation will be measured continuously through the child's hospital stay until discharge.
Other: Continuous oxygen monitoring
Oxygen saturation will be measured continuously through the child's hospital stay until discharge. Vital signs will be completed every 4 hours.
Other Name: Continuous

Experimental: Intermittent oxygen monitoring
Oxygen saturation will be measured intermittently, every 4 hours, through the child's hospital stay until discharge.
Other: Intermittent oxygen monitoring
Oxygen saturation and vital signs will be measured intermittently at a frequency of every 4 hours by the bedside nurse through the child's hospital stay until discharge. Vital signs will be completed every 4 hours.
Other Name: Intermittent

Primary Outcome Measures :
  1. Length of hospital stay from randomization on the inpatient unit to discharge from hospital [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Duration of oxygen supplementation from randomization to discontinuation of supplementation [ Time Frame: 1 month ]
  2. Number of medical interventions performed from time of randomization to hospital discharge [ Time Frame: 1 month ]
  3. Time from randomization to meeting hospital discharge criteria [ Time Frame: 1 month ]
  4. Length of hospital stay from inpatient unit admission to hospital discharge [ Time Frame: 1 month ]
  5. Parent anxiety [ Time Frame: 1 month ]
    Parents will rate their level of anxiety at the current time (state anxiety) and generally (trait anxiety) from the adult State Trait Anxiety Inventory questionnaire during the hospital stay.

  6. Number of parent work days missed from randomization to 15 days after discharge [ Time Frame: 15 days after discharge ]
  7. Nursing satisfaction [ Time Frame: 1 month ]
    The attending nurse will be asked to complete a 10 mm visual analogue scale (VAS) to measure their satisfaction with the quality of monitoring.

  8. PICU admission after randomization [ Time Frame: 1 month ]
  9. PICU consultation after admission [ Time Frame: 1 month ]
  10. Unscheduled return to care within 15 days of discharge [ Time Frame: 15 days after discharge ]
  11. Mortality [ Time Frame: 15 days after discharge. ]
  12. Cost-Effectiveness [ Time Frame: 15 days after discharge. ]
    Cost-effectiveness will be measured by the incremental cost-effectiveness ratio (ICER), a ratio defined by the incremental difference in costs between treatment arms and the incremental difference in length of stay.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Children admitted to the general pediatric inpatient unit (GPIU) with bronchiolitis will be eligible if their clinical status is stable and not at high risk of deterioration

Inclusion Criteria:

  • Clinical diagnosis of bronchiolitis as determined by the attending physician.
  • First episode of acute bronchiolitis.
  • Age: 4 weeks to 24 months.
  • Clinical status stable for 6 hours
  • Parent consent

Exclusion Criteria:

  • Known risk factors for clinical deterioration including chronic medical condition; premature birth (<35weeks), history of apnea, weight < 4kg, receiving morphine
  • Patient on heated high flow oxygen at enrolment
  • ICU admission on current admission
  • No telephone available

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 identifier (NCT number): NCT02947204

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Canada, Ontario
McMaster Children's Hospital
Hamilton, Ontario, Canada, L8N 2Z5
Trillium Health Partners (Credit Valley Site)
Mississauga, Ontario, Canada, L5B 1B8
Lakeridge Health Oshawa
Oshawa, Ontario, Canada, L1G 2B9
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
North York General Hospital
Toronto, Ontario, Canada, M2K 1E1
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Canadian Institutes of Health Research (CIHR)
Children's Hospital of Eastern Ontario
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Principal Investigator: Sanjay Mahant The Hospital for Sick Children

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sanjay Mahant, Staff Physician, The Hospital for Sick Children Identifier: NCT02947204    
Other Study ID Numbers: 1000054699
First Posted: October 27, 2016    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sanjay Mahant, The Hospital for Sick Children:
Length of Hospital Stay
Clinical Trial
Oxygen Saturation Monitoring
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections