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Completed

NCT Number: NCT02947204

Oxygen Saturation Monitoring in Bronchiolitis

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.

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Key information

Age range

4 week–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster Children's Hospital, Hamilton, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intermittent oxygen monitoring

Other

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

Continuous oxygen monitoring

Other

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

Primary outcomes

  1. Length of hospital stay from randomization on the inpatient unit to discharge from hospital

    Time frame: 1 month

Secondary outcomes

  1. Duration of oxygen supplementation from randomization to discontinuation of supplementation

    Time frame: 1 month

  2. Number of medical interventions performed from time of randomization to hospital discharge

    Time frame: 1 month

  3. Time from randomization to meeting hospital discharge criteria

    Time frame: 1 month

  4. Length of hospital stay from inpatient unit admission to hospital discharge

    Time frame: 1 month

  5. 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.

  6. Number of parent work days missed from randomization to 15 days after discharge

    Time frame: 15 days after discharge

  7. 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.

  8. PICU admission after randomization

    Time frame: 1 month

  9. PICU consultation after admission

    Time frame: 1 month

  10. Unscheduled return to care within 15 days of discharge

    Time frame: 15 days after discharge

  11. Mortality

    Time frame: 15 days after discharge.

  12. 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.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Children's Hospital of Eastern Ontario

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 27, 2016
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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