Intermittent Versus Continuous Pulse Oximetry Monitoring of Infants Admitted for Bronchiolitis
Primary Purpose
Bronchiolitis, Hypoxia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous pulse oximetry monitoring
Intermittent pulse oximetry monitoring
Sponsored by
About this trial
This is an interventional supportive care trial for Bronchiolitis focused on measuring Bronchiolitis, Hypoxia, Pulse, Oximetry, Hospitalized
Eligibility 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
Sites / Locations
- University of Missouri Children's Hospital
- Children's Mercy Hospital
- Hasbro Children's Hospital
- Christus Santa Rosa Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Continuous pulse oximetry monitoring
Intermittent pulse oximetry monitoring
Arm Description
Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen.
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.
Outcomes
Primary Outcome Measures
Length of Stay in the Hospital
Secondary Outcome Measures
Clinical Deterioration Necessitating Transfer to Higher Level of Care
Full Information
NCT ID
NCT01014910
First Posted
November 16, 2009
Last Updated
August 20, 2021
Sponsor
Children's Mercy Hospital Kansas City
Collaborators
Baylor University, Lifespan, University of Missouri, Kansas City
1. Study Identification
Unique Protocol Identification Number
NCT01014910
Brief Title
Intermittent Versus Continuous Pulse Oximetry Monitoring of Infants Admitted for Bronchiolitis
Official Title
Intermittent Versus Continuous Pulse Oximetry Monitoring of Infants Admitted for Bronchiolitis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Mercy Hospital Kansas City
Collaborators
Baylor University, Lifespan, University of Missouri, Kansas City
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis, Hypoxia
Keywords
Bronchiolitis, Hypoxia, Pulse, Oximetry, Hospitalized
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
161 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Continuous pulse oximetry monitoring
Arm Type
Active Comparator
Arm Description
Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen.
Arm Title
Intermittent pulse oximetry monitoring
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Continuous pulse oximetry monitoring
Other Intervention Name(s)
Continuous pulse ox
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Intermittent pulse oximetry monitoring
Other Intervention Name(s)
Intermittent pulse ox
Intervention Description
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.
Primary Outcome Measure Information:
Title
Length of Stay in the Hospital
Time Frame
Summarized from admission to hospital discharge
Secondary Outcome Measure Information:
Title
Clinical Deterioration Necessitating Transfer to Higher Level of Care
Time Frame
Summarized from admission to hospital discharge
10. Eligibility
Sex
All
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael P Koster, MD
Organizational Affiliation
Hasbro Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Russell J McCulloh, MD
Organizational Affiliation
Children's Mercy Hospital Kansas City
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vanessa Hill, MD
Organizational Affiliation
Christus Santa Rosa Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri Children's Hospital
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Hasbro Children's Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Christus Santa Rosa Children's Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IRB approval at participating institutions does not provide an avenue for sharing study data after study completion.
Citations:
PubMed Identifier
11076709
Citation
Shay DK, Holman RC, Roosevelt GE, Clarke MJ, Anderson LJ. Bronchiolitis-associated mortality and estimates of respiratory syncytial virus-associated deaths among US children, 1979-1997. J Infect Dis. 2001 Jan 1;183(1):16-22. doi: 10.1086/317655. Epub 2000 Nov 10.
Results Reference
background
PubMed Identifier
11581435
Citation
Willson DF, Horn SD, Hendley JO, Smout R, Gassaway J. Effect of practice variation on resource utilization in infants hospitalized for viral lower respiratory illness. Pediatrics. 2001 Oct;108(4):851-5. doi: 10.1542/peds.108.4.851.
Results Reference
background
PubMed Identifier
15342857
Citation
Bass JL, Corwin M, Gozal D, Moore C, Nishida H, Parker S, Schonwald A, Wilker RE, Stehle S, Kinane TB. The effect of chronic or intermittent hypoxia on cognition in childhood: a review of the evidence. Pediatrics. 2004 Sep;114(3):805-16. doi: 10.1542/peds.2004-0227.
Results Reference
background
PubMed Identifier
10547246
Citation
Hunt CE, Corwin MJ, Lister G, Weese-Mayer DE, Neuman MR, Tinsley L, Baird TM, Keens TG, Cabral HJ. Longitudinal assessment of hemoglobin oxygen saturation in healthy infants during the first 6 months of age. Collaborative Home Infant Monitoring Evaluation (CHIME) Study Group. J Pediatr. 1999 Nov;135(5):580-6. doi: 10.1016/s0022-3476(99)70056-9.
Results Reference
background
PubMed Identifier
15184226
Citation
Bergman AB. Pulse oximetry: good technology misapplied. Arch Pediatr Adolesc Med. 2004 Jun;158(6):594-5. doi: 10.1001/archpedi.158.6.594. No abstract available.
Results Reference
background
PubMed Identifier
18310194
Citation
Unger S, Cunningham S. Effect of oxygen supplementation on length of stay for infants hospitalized with acute viral bronchiolitis. Pediatrics. 2008 Mar;121(3):470-5. doi: 10.1542/peds.2007-1135.
Results Reference
background
PubMed Identifier
20636429
Citation
Luo Z, Fu Z, Liu E, Xu X, Fu X, Peng D, Liu Y, Li S, Zeng F, Yang X. Nebulized hypertonic saline treatment in hospitalized children with moderate to severe viral bronchiolitis. Clin Microbiol Infect. 2011 Dec;17(12):1829-33. doi: 10.1111/j.1469-0691.2010.03304.x. Epub 2010 Jul 15.
Results Reference
background
PubMed Identifier
20713480
Citation
Ralston S, Hill V, Martinez M. Nebulized hypertonic saline without adjunctive bronchodilators for children with bronchiolitis. Pediatrics. 2010 Sep;126(3):e520-5. doi: 10.1542/peds.2009-3105. Epub 2010 Aug 16.
Results Reference
background
PubMed Identifier
26322819
Citation
McCulloh R, Koster M, Ralston S, Johnson M, Hill V, Koehn K, Weddle G, Alverson B. Use of Intermittent vs Continuous Pulse Oximetry for Nonhypoxemic Infants and Young Children Hospitalized for Bronchiolitis: A Randomized Clinical Trial. JAMA Pediatr. 2015 Oct;169(10):898-904. doi: 10.1001/jamapediatrics.2015.1746.
Results Reference
derived
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Intermittent Versus Continuous Pulse Oximetry Monitoring of Infants Admitted for Bronchiolitis
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