N/A
N=161
Intermittent Versus Continuous Pulse Oximetry Monitoring of Infants Admitted for Bronchiolitis
Bronchiolitis · Hypoxia
Bottom Line
View on ClinicalTrials.gov: NCT01014910 ↗Enrolled (actual)
161
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Length of Stay in the Hospital — 38.7; 39.5 hours — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Continuous pulse oximetry monitoring (Other); Intermittent pulse oximetry monitoring (Device)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Children's Mercy Hospital Kansas City
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Length of Stay in the Hospital |
38.7; 39.5 | <0.05 sig |
| SECONDARY Clinical Deterioration Necessitating Transfer to Higher Level of Care |
4; 4 | 0.05 |
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.
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
Data sourced from ClinicalTrials.gov (NCT01014910). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.