Oxygen Saturation Monitoring in Bronchiolitis

Bronchiolitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02947204
• Other study ID #: 1000054699
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: May 2019

Study information

• Verified date: March 2020
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	McMaster Children's Hospital	Hamilton	Ontario
Canada	Trillium Health Partners (Credit Valley Site)	Mississauga	Ontario
Canada	Lakeridge Health Oshawa	Oshawa	Ontario
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario
Canada	Hospital for Sick Children	Toronto	Ontario
Canada	North York General Hospital	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Canadian Institutes of Health Research (CIHR), Children's Hospital of Eastern Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospital stay from randomization on the inpatient unit to discharge from hospital		1 month
Secondary	Duration of oxygen supplementation from randomization to discontinuation of supplementation		1 month
Secondary	Number of medical interventions performed from time of randomization to hospital discharge		1 month
Secondary	Time from randomization to meeting hospital discharge criteria		1 month
Secondary	Length of hospital stay from inpatient unit admission to hospital discharge		1 month
Secondary	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
Secondary	Number of parent work days missed from randomization to 15 days after discharge		15 days after discharge
Secondary	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
Secondary	PICU admission after randomization		1 month
Secondary	PICU consultation after admission		1 month
Secondary	Unscheduled return to care within 15 days of discharge		15 days after discharge
Secondary	Mortality		15 days after discharge.
Secondary	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.