Clinical trial NCT01014910: 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
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiolitis
Hypoxia
Keywords: Bronchiolitis
Hypoxia
Pulse
Oximetry
Hospitalized
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
Collaborators: name: Baylor University
name: Lifespan
name: University of Missouri, Kansas City
First posted: 2009-11-17
Enrollment: 161
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Length of Stay in the Hospital
timeFrame: Summarized from admission to hospital discharge
Secondary outcomes:
measure: Clinical Deterioration Necessitating Transfer to Higher Level of Care
timeFrame: Summarized from admission to hospital discharge
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri Children's Hospital
state: Missouri
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Providence
country: United States
facility: Hasbro Children's Hospital
state: Rhode Island
city: San Antonio
country: United States
facility: Christus Santa Rosa Children's Hospital
state: Texas
Study officials:
affiliation: Hasbro Children's Hospital
name: Michael P Koster, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Mercy Hospital Kansas City
name: Russell J McCulloh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Christus Santa Rosa Children's Hospital
name: Vanessa Hill, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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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.
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.
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.
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.
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.
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.