Clinical trial NCT02947204: Oxygen Saturation Monitoring in Bronchiolitis
Official title: Intermittent vs. Continuous Oxygen Saturation Monitoring in Infants Hospitalized for Bronchiolitis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiolitis
Keywords: Bronchiolitis
Length of Hospital Stay
Clinical Trial
Oxygen Saturation Monitoring
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Children's Hospital of Eastern Ontario
First posted: 2016-10-27
Enrollment: 219
Sex: ALL
Minimum age (years): 4
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 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

Primary outcomes:
measure: Length of hospital stay from randomization on the inpatient unit to discharge from hospital
timeFrame: 1 month
Secondary outcomes:
measure: Duration of oxygen supplementation from randomization to discontinuation of supplementation
timeFrame: 1 month
measure: Number of medical interventions performed from time of randomization to hospital discharge
timeFrame: 1 month
measure: Time from randomization to meeting hospital discharge criteria
timeFrame: 1 month
measure: Length of hospital stay from inpatient unit admission to hospital discharge
timeFrame: 1 month
measure: Parent anxiety
timeFrame: 1 month
measure: Number of parent work days missed from randomization to 15 days after discharge
timeFrame: 15 days after discharge
measure: Nursing satisfaction
timeFrame: 1 month
measure: PICU admission after randomization
timeFrame: 1 month
measure: PICU consultation after admission
timeFrame: 1 month
measure: Unscheduled return to care within 15 days of discharge
timeFrame: 15 days after discharge
measure: Mortality
timeFrame: 15 days after discharge.
measure: Cost-Effectiveness
timeFrame: 15 days after discharge.
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
city: Mississauga
country: Canada
facility: Trillium Health Partners (Credit Valley Site)
state: Ontario
city: Oshawa
country: Canada
facility: Lakeridge Health Oshawa
state: Ontario
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
city: Toronto
country: Canada
facility: North York General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Sanjay Mahant
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Mahant 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.