Intermittent Versus Continuous Pulse Oximetry Monitoring of Infants Admitted for Bronchiolitis

NCT01014910 | Completed Results DMC

• 1 other identifier: CMTT# 4151-09
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 4

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.

Conditions

Bronchiolitis; Hypoxia

Keywords

Bronchiolitis; Hypoxia; Pulse; Oximetry; Hospitalized

Outcome Measures

Primary Outcomes (1)

• Length of Stay in the Hospital

  Summarized from admission to hospital discharge

Secondary Outcomes (1)

• Clinical Deterioration Necessitating Transfer to Higher Level of Care

  Summarized from admission to hospital discharge

Study Arms (2)

Continuous pulse oximetry monitoring

ACTIVE COMPARATOR

Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen.

Other: Continuous pulse oximetry monitoring

Intermittent pulse oximetry monitoring

ACTIVE COMPARATOR

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

Interventions

Continuous pulse oximetry monitoring OTHER

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.

Also known as: Continuous pulse ox

Continuous pulse oximetry monitoring

Intermittent pulse oximetry monitoring DEVICE

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.

Also known as: Intermittent pulse ox

Intermittent pulse oximetry monitoring

Eligibility Criteria

• Age: Up to 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead
• Baylor University: collaborator
• Lifespan: collaborator
• University of Missouri, Kansas City: collaborator

Study Sites (4)

University of Missouri Children's Hospital

Columbia, Missouri, 65212, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Hasbro Children's Hospital

Providence, Rhode Island, 02903, United States

Location

Christus Santa Rosa Children's Hospital

San Antonio, Texas, 78207, United States

Location

Related Publications (9)

• 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.

  PMID: 11076709 BACKGROUND

• 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.

  PMID: 11581435 BACKGROUND

• 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.

  PMID: 15342857 BACKGROUND

• 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.

  PMID: 10547246 BACKGROUND

• 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.

  PMID: 15184226 BACKGROUND

• 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.

  PMID: 18310194 BACKGROUND

• 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.

  PMID: 20636429 BACKGROUND

• 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.

  PMID: 20713480 BACKGROUND

• 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.

  PMID: 26322819 DERIVED

MeSH Terms

Conditions

Bronchiolitis; Hypoxia

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Our study was not designed or powered to detect differences in ICU transfers.

Results Point of Contact

• Title: Dr. Russell McCulloh
• Organization: Children's Mercy Hospital Kansas City

rmcculloh@cmh.edu

816-234-3061

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2009
• First Posted: November 17, 2009
• Study Start: December 1, 2009
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 16, 2021
• Results First Posted: March 21, 2016

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)