Oxygen Saturation Monitoring in Bronchiolitis
Intermittent vs. Continuous Oxygen Saturation Monitoring in Infants Hospitalized for Bronchiolitis: A Randomized Controlled Trial
1 other identifier
interventional
219
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2016
Typical duration for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2016
CompletedFirst Posted
Study publicly available on registry
October 27, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedMarch 24, 2020
March 1, 2020
2.5 years
October 20, 2016
March 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Length of hospital stay from randomization on the inpatient unit to discharge from hospital
1 month
Secondary Outcomes (12)
Duration of oxygen supplementation from randomization to discontinuation of supplementation
1 month
Number of medical interventions performed from time of randomization to hospital discharge
1 month
Time from randomization to meeting hospital discharge criteria
1 month
Length of hospital stay from inpatient unit admission to hospital discharge
1 month
Parent anxiety
1 month
- +7 more secondary outcomes
Study Arms (2)
Continuous oxygen monitoring
ACTIVE COMPARATOROxygen saturation will be measured continuously through the child's hospital stay until discharge.
Intermittent oxygen monitoring
EXPERIMENTALOxygen saturation will be measured intermittently, every 4 hours, through the child's hospital stay until discharge.
Interventions
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.
Oxygen saturation will be measured continuously through the child's hospital stay until discharge. Vital signs will be completed every 4 hours.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
McMaster Children's Hospital
Hamilton, Ontario, L8N 2Z5, Canada
Trillium Health Partners (Credit Valley Site)
Mississauga, Ontario, L5B 1B8, Canada
Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1, Canada
North York General Hospital
Toronto, Ontario, M2K 1E1, Canada
Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
Related Publications (2)
Mahant S, Wahi G, Bayliss A, Giglia L, Kanani R, Pound CM, Sakran M, Kozlowski N, Breen-Reid K, Arafeh D, Moretti ME, Agarwal A, Barrowman N, Willan AR, Schuh S, Parkin PC; Canadian Paediatric Inpatient Research Network (PIRN). Intermittent vs Continuous Pulse Oximetry in Hospitalized Infants With Stabilized Bronchiolitis: A Randomized Clinical Trial. JAMA Pediatr. 2021 May 1;175(5):466-474. doi: 10.1001/jamapediatrics.2020.6141.
PMID: 33646286DERIVEDMahant S, Wahi G, Giglia L, Pound C, Kanani R, Bayliss A, Roy M, Sakran M, Kozlowski N, Breen-Reid K, Lavigne M, Premji L, Moretti ME, Willan AR, Schuh S, Parkin PC. Intermittent versus continuous oxygen saturation monitoring for infants hospitalised with bronchiolitis: study protocol for a pragmatic randomised controlled trial. BMJ Open. 2018 Apr 20;8(4):e022707. doi: 10.1136/bmjopen-2018-022707.
PMID: 29678995DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sanjay Mahant
The Hospital for Sick Children
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff Physician
Study Record Dates
First Submitted
October 20, 2016
First Posted
October 27, 2016
Study Start
November 1, 2016
Primary Completion
May 1, 2019
Study Completion
May 1, 2019
Last Updated
March 24, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share