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Intermittent Versus Continuous Pulse Oximetry Monitoring of Infants Admitted for Bronchiolitis

This study has been completed.
Sponsor:
Collaborators:
Baylor University
Lifespan
University of Missouri, Kansas City
Information provided by (Responsible Party):
Russell McCulloh, University of Missouri, Kansas City
ClinicalTrials.gov Identifier:
NCT01014910
First received: November 16, 2009
Last updated: September 24, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Bronchiolitis
Hypoxia
Other: Continuous pulse oximetry monitoring
Device: Intermittent pulse oximetry monitoring

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Intermittent Versus Continuous Pulse Oximetry Monitoring of Infants Admitted for Bronchiolitis

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • Length of stay in the hospital [ Time Frame: At 6 month intervals and enrollment of 100, 200, and study completion. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cost of hospital stay [ Time Frame: At 6 month intervals and enrollment of 100, 200, and study completion. ] [ Designated as safety issue: No ]
  • Clinical deterioration necessitating transfer to higher level of care [ Time Frame: At 6 month intervals and at 100, 200, and study completion. ] [ Designated as safety issue: Yes ]

Enrollment: 161
Study Start Date: December 2009
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Intermittent pulse ox

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.

  Eligibility

Ages Eligible for Study:   up to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01014910

Locations
United States, Missouri
University of Missouri Children's Hospital
Columbia, Missouri, United States, 65212
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
United States, Rhode Island
Hasbro Children's Hospital
Providence, Rhode Island, United States, 02903
United States, Texas
Christus Santa Rosa Children's Hospital
San Antonio, Texas, United States, 78207
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Baylor University
Lifespan
University of Missouri, Kansas City
Investigators
Principal Investigator: Michael P Koster, MD Hasbro Children's Hospital
Principal Investigator: Russell J McCulloh, MD Children's Mercy Hospital
Principal Investigator: Vanessa Hill, MD Christus Santa Rosa Children's Hospital
  More Information

Publications:

Responsible Party: Russell McCulloh, Assistant Professor, Pediatric Infectious Diseases, University of Missouri, Kansas City
ClinicalTrials.gov Identifier: NCT01014910     History of Changes
Other Study ID Numbers: CMTT# 4151-09
Study First Received: November 16, 2009
Last Updated: September 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:
Bronchiolitis
Hypoxia
Pulse
Oximetry
Hospitalized

Additional relevant MeSH terms:
Bronchiolitis
Bronchial Diseases
Bronchitis
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on November 27, 2014