Intermittent Versus Continuous Pulse Oximetry Monitoring of Infants Admitted for Bronchiolitis
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| ClinicalTrials.gov Identifier: NCT01014910 |
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Recruitment Status :
Completed
First Posted : November 17, 2009
Results First Posted : March 21, 2016
Last Update Posted : March 21, 2016
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Bronchiolitis Hypoxia | Other: Continuous pulse oximetry monitoring Device: Intermittent pulse oximetry monitoring | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 161 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | Intermittent Versus Continuous Pulse Oximetry Monitoring of Infants Admitted for Bronchiolitis |
| Study Start Date : | December 2009 |
| Actual Primary Completion Date : | September 2014 |
| Actual Study Completion Date : | September 2014 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Continuous pulse oximetry monitoring
Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen.
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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 |
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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.
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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 |
- Length of Stay in the Hospital [ Time Frame: Summarized from admission to hospital discharge ]
- Clinical Deterioration Necessitating Transfer to Higher Level of Care [ Time Frame: Summarized from admission to hospital discharge ]
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| Ages Eligible for Study: | up to 24 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01014910
| 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 | |
| Principal Investigator: | 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 |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Russell McCulloh, Assistant Professor, Pediatric Infectious Diseases, Children's Mercy Hospital Kansas City |
| ClinicalTrials.gov Identifier: | NCT01014910 History of Changes |
| Other Study ID Numbers: |
CMTT# 4151-09 |
| First Posted: | November 17, 2009 Key Record Dates |
| Results First Posted: | March 21, 2016 |
| Last Update Posted: | March 21, 2016 |
| Last Verified: | February 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | IRB approval at participating institutions does not provide an avenue for sharing study data after study completion. |
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Bronchiolitis Hypoxia Pulse Oximetry Hospitalized |
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Bronchiolitis Hypoxia Signs and Symptoms, Respiratory Signs and Symptoms Bronchitis |
Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Tract Infections |