Intermittent Versus Continuous Pulse Oximetry Monitoring of Infants Admitted for Bronchiolitis

August 20, 2021 updated by: Children's Mercy Hospital Kansas City

Bronchiolitis is a lower respiratory tract infection (LRTI) syndrome cause by different types of viruses and occurs in young children. Although bronchiolitis is a widespread and fairly common illness in children, pediatricians vary significantly in how it is treated. This includes how children are monitored for their oxygen status when not receiving supplemental oxygen. Studies suggest that continuous pulse oximetry measurement of children admitted to the hospital with bronchiolitis regardless of use of supplemental oxygen prolongs their hospital stay. This increases the cost of care for these patients and increases their risk of hospital-associated complications.

This study is a randomized trial of continuous pulse oximeter use in patients admitted with bronchiolitis versus transitioning patients not requiring oxygen to intermittent pulse oximetry monitoring. The investigators hypothesize that this will decrease length of stay as well as associated costs of care and number of medical interventions performed in the hospital.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Bronchiolitis is a lower respiratory tract infection (LRTI) syndrome caused by different viruses. It is the most common LRTI in children under 24 months old, accounting for approximately 90,000 hospitalizations annually and costing over $700 million in children under 12 months. Health care providers vary in diagnosis and management, however. In 2006 the American Academy of Pediatrics (AAP) released guidelines for bronchiolitis management in an effort to standardize clinical practice. Part of these guidelines recommends patients admitted to the hospital receive supplemental oxygen if they are persistently hypoxic, which is defined as pulse oximeter readings persistently below 90%. However, this recommendation is based on expert opinion.

Research has previously shown healthy infants routinely experience brief episodes of decreased oxygen levels while sleeping without significant health effects. Other studies demonstrate no relationship between short intervals of transient or mildly decreased oxygen levels and long-term mental or developmental delays. Furthermore, children with bronchiolitis remain hospitalized longer without any appreciable improvement in the course or outcome of their illness when continuously monitored for oxygen level.

Widespread pulse oximeter use has increased hospitalization rates over 250%, and close monitoring increases length of stay for children who otherwise could be discharged home. The 2006 guidelines discourage continuous pulse oximetry monitoring in children not requiring supplemental oxygen, but health care providers routinely ignore this recommendation. No studies have assessed the impact of more strictly adhering to the practices recommended by the AAP.

Research Procedures: This is a randomized control study and is a multi-site collaboration with University of Missouri Children's Hospital in Columbia, Missouri. Children admitted to the study sites with bronchiolitis will be batch randomized (i.e. randomized separately at each site) to undergo either continuous pulse oximetry monitoring throughout the entire hospitalization or receive intermittent monitoring when not on supplemental oxygen. Patients will additionally receive all care standard to the management of their illness. Of note, the proposed intervention is the recommended standard of care for oxygen monitoring compared to the general practice used at both study sites. Researchers will then review charts after discharge for length of stay, number of medical interventions performed, diagnostic testing completed, and treatments provided. Cost of stay for patients in each group will be estimated and compared as well. Patients will be involved in the study for their entire admission.

Study Type

Interventional

Enrollment (Actual)

161

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri Children's Hospital
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Hasbro Children's Hospital
    • Texas
      • San Antonio, Texas, United States, 78207
        • Christus Santa Rosa Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children less than or equal to 24 months old with a history of term delivery (gestational age ≥37 weeks) admitted with a presumptive diagnosis of bronchiolitis
  • Bronchiolitis will be defined as an episode of wheezing or increased work of breathing associated with signs of an upper respiratory tract infection experienced by a patient
  • Enrollment within 24 hours of admission

Exclusion Criteria:

  • History of severe cardiac or pulmonary illness, including but not limited to bronchopulmonary dysplasia, chronic lung disease, asthma/reactive airway disease, congenital heart disease, heart failure, and cardiothoracic surgery
  • History of home albuterol use for asthma or reactive airway disease
  • History of use of bronchodilator with successful patient response to the medication
  • Use of corticosteroids within the past two weeks up to day of admission
  • Use of antibiotics after admission for suspected pneumonia or similar pulmonary disease
  • History of premature birth (<37 weeks gestation)
  • History of receiving palivizumab (anti-RSV antibody)
  • Diagnosis of chronic immune deficiency, hematologic dyscrasia, or cancer
  • Chronic treatment with immunosuppressants
  • Parents/guardians unable to give informed consent in English
  • Need for PICU transfer at any point during illness
  • Transfer from an outside institution where patient was hospitalized for ≥12 hours
  • Previous enrollment in this study
  • Pediatric attending refuses to comply with study protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Continuous pulse oximetry monitoring
Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen.
Other: Continuous pulse oximetry monitoring
Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen.
Other Names:
  • Continuous pulse ox
Active Comparator: Intermittent pulse oximetry monitoring
Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved.
Device: Intermittent pulse oximetry monitoring
Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved.
Other Names:
  • Intermittent pulse ox

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Length of Stay in the Hospital
Time Frame: Summarized from admission to hospital discharge
Summarized from admission to hospital discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical Deterioration Necessitating Transfer to Higher Level of Care
Time Frame: Summarized from admission to hospital discharge
Summarized from admission to hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Mercy Hospital Kansas City

Collaborators

Baylor University
University of Missouri, Kansas City
Lifespan

Investigators

  • Principal Investigator: Michael P Koster, MD, Hasbro Children's Hospital
  • Principal Investigator: Russell J McCulloh, MD, Children's Mercy Hospital Kansas City
  • Principal Investigator: Vanessa Hill, MD, Christus Santa Rosa Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

November 16, 2009

First Submitted That Met QC Criteria

November 16, 2009

First Posted (Estimate)

November 17, 2009

Study Record Updates

Last Update Posted (Actual)

September 16, 2021

Last Update Submitted That Met QC Criteria

August 20, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMTT# 4151-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IRB approval at participating institutions does not provide an avenue for sharing study data after study completion.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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