Oxygen Saturation Monitoring in Bronchiolitis
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|ClinicalTrials.gov Identifier: NCT02947204|
Recruitment Status : Recruiting
First Posted : October 27, 2016
Last Update Posted : October 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Bronchiolitis||Other: Intermittent oxygen monitoring Other: Continuous oxygen monitoring||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Intermittent vs. Continuous Oxygen Saturation Monitoring in Infants Hospitalized for Bronchiolitis: A Randomized Controlled Trial|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||November 2018|
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
- Length of hospital stay from randomization on the inpatient unit to discharge from hospital [ Time Frame: 1 month ]
- 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.
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
|Contact: Sanjay Mahantemail@example.com|
|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 firstname.lastname@example.org|
|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|
|Principal Investigator:||Sanjay Mahant||The Hospital for Sick Children|