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Oxygen Saturation Monitoring in Bronchiolitis

This study is currently recruiting participants.
Verified October 2017 by Sanjay Mahant, The Hospital for Sick Children
Sponsor:
ClinicalTrials.gov Identifier:
NCT02947204
First Posted: October 27, 2016
Last Update Posted: October 18, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Canadian Institutes of Health Research (CIHR)
Children's Hospital of Eastern Ontario
Information provided by (Responsible Party):
Sanjay Mahant, The Hospital for Sick Children
  Purpose
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 Intervention
Bronchiolitis Other: Intermittent oxygen monitoring Other: Continuous oxygen monitoring

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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

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

Secondary Outcome Measures:
  • Duration of oxygen supplementation from randomization to discontinuation of supplementation [ Time Frame: 1 month ]
  • Number of medical interventions performed from time of randomization to hospital discharge [ Time Frame: 1 month ]
  • Time from randomization to meeting hospital discharge criteria [ Time Frame: 1 month ]
  • Length of hospital stay from triage in the emergency department to hospital discharge [ Time Frame: 1 month ]
  • 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.

  • Number of parent work days missed from randomization to 15 days after discharge [ Time Frame: 15 days after discharge ]
  • 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.

  • PICU admission after randomization [ Time Frame: 1 month ]
  • PICU consultation after admission [ Time Frame: 1 month ]
  • Unscheduled return to care within 15 days of discharge [ Time Frame: 15 days after discharge ]
  • Mortality [ Time Frame: 15 days after discharge. ]
  • 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.


Estimated Enrollment: 210
Study Start Date: November 2016
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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): NCT02947204


Contacts
Contact: Sanjay Mahant 416-813-8422 sanjay.mahant@sickkids.ca

Locations
Canada, Ontario
McMaster Children's Hospital Recruiting
Hamilton, Ontario, Canada, L8N 2Z5
Contact: Lucy Giglia, MD         
Principal Investigator: Lucy Giglia, MD         
Principal Investigator: Gita Wahi, MD         
Trillium Health Partners (Credit Valley Site) Recruiting
Mississauga, Ontario, Canada, L5B 1B8
Contact: Ann Bayliss, MD         
Principal Investigator: Ann Bayliss         
Lakeridge Health Oshawa Recruiting
Oshawa, Ontario, Canada, L1G 2B9
Contact: Mahmoud Sakran, MD         
Principal Investigator: Mahmoud Sakran, MD         
Children's Hospital of Eastern Ontario Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: Catherine Pound, MD         
Principal Investigator: Catherine Pound, MD         
North York General Hospital Recruiting
Toronto, Ontario, Canada, M2K 1E1
Contact: Ronik Kanani, MD         
Principal Investigator: Ronik Kanani, MD         
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Sanjay Mahant, MD, MSc       sanjay.mahant@sickkids.ca   
Principal Investigator: Sanjay Mahant, MD, MSc         
Sub-Investigator: Myla Moretti, PhD         
Sub-Investigator: Patricia Parkin, MD         
Sub-Investigator: Suzanne Schuh, MD         
Sub-Investigator: Andy Willan, PhD         
Sponsors and Collaborators
The Hospital for Sick Children
Canadian Institutes of Health Research (CIHR)
Children's Hospital of Eastern Ontario
Investigators
Principal Investigator: Sanjay Mahant The Hospital for Sick Children
  More Information

Responsible Party: Sanjay Mahant, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02947204     History of Changes
Other Study ID Numbers: 1000054699
First Submitted: October 20, 2016
First Posted: October 27, 2016
Last Update Posted: October 18, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Sanjay Mahant, The Hospital for Sick Children:
Bronchiolitis
Length of Hospital Stay
Clinical Trial
Oxygen Saturation Monitoring

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