Oxygen Saturation Monitoring in Bronchiolitis

Intermittent vs. Continuous Oxygen Saturation Monitoring in Infants Hospitalized for Bronchiolitis: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Bronchiolitis
• Intervention / Treatment: Other: Continuous oxygen monitoring; Other: Intermittent oxygen monitoring

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.

• Study Type: Interventional
• Enrollment (Actual): 219
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 2Z5
      • McMaster Children's Hospital
    • Mississauga, Ontario, Canada, L5B 1B8
      • Trillium Health Partners (Credit Valley Site)
    • Oshawa, Ontario, Canada, L1G 2B9
      • Lakeridge Health Oshawa
    • Ottawa, Ontario, Canada, K1H 8L1
      • Children's Hospital of Eastern Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • Hospital for Sick Children
    • Toronto, Ontario, Canada, M2K 1E1
      • North York General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Intermittent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Length of hospital stay from randomization on the inpatient unit to discharge from hospital	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	1 month
Number of parent work days missed from randomization to 15 days after discharge		15 days after discharge
Nursing satisfaction	The attending nurse will be asked to complete a 10 mm visual analogue scale (VAS) to measure their satisfaction with the quality of monitoring.	1 month
PICU admission after randomization		1 month
PICU consultation after admission		1 month
Unscheduled return to care within 15 days of discharge		15 days after discharge
Mortality		15 days after discharge.
Cost-Effectiveness	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.	15 days after discharge.

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: Canadian Institutes of Health Research (CIHR); Children's Hospital of Eastern Ontario
• Investigators: Principal Investigator: Sanjay Mahant, The Hospital for Sick Children

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: October 20, 2016
• First Submitted That Met QC Criteria: October 25, 2016
• First Posted (Estimate): October 27, 2016

Study Record Updates

• Last Update Posted (Actual): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 20, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Clinical Trial; Bronchiolitis; Length of Hospital Stay; Oxygen Saturation Monitoring
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis
• Other Study ID Numbers: 1000054699

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No