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| Name | Class |
|---|---|
| Baylor University | OTHER |
| Lifespan | OTHER |
| University of Missouri, Kansas City | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous pulse oximetry monitoring | Active Comparator | Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay in the Hospital | Summarized from admission to hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Deterioration Necessitating Transfer to Higher Level of Care | Summarized from admission to hospital discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri Children's Hospital | Columbia | Missouri | 65212 | United States | ||
| Children's Mercy Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11076709 | Background | 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. | |
| 11581435 | 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. |
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IRB approval at participating institutions does not provide an avenue for sharing study data after study completion.
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Participants were sequentially randomized at each site in strict chronological order of hospital admission each day. Screening of participants was performed on weekdays during normal business hours. only. Parents/guardians were blinded to allocation assignment until informed consent was obtained; study personnel and outcome assessors were not.
Recruitment occurred from October 2009 to April 2014. Only 1 study site used an institutional clinical practice guideline during the study. Respiratory-distress scoring systems for hospitalized patients were not standardized across sites. All sites used an oxygen saturation level of 90% or higher in room air as a criterion for hospital discharge.
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| ID | Title | Description |
|---|---|---|
| FG000 | Continuous Pulse Oximetry Monitoring | Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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. |
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| Kansas City |
| Missouri |
| 64108 |
| United States |
| Hasbro Children's Hospital | Providence | Rhode Island | 02903 | United States |
| Christus Santa Rosa Children's Hospital | San Antonio | Texas | 78207 | United States |
| 15342857 | 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. |
| 10547246 | 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. |
| 15184226 | 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. |
| 18310194 | 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. |
| 20636429 | 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. |
| 20713480 | 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. |
| 26322819 | Derived | 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. |
| FG001 | 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. 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. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Continuous Pulse Oximetry Monitoring | Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen. 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. |
| BG001 | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Presence of rhonorrhea | Number | participants |
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| Decreased oral intake | Number | participants |
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| Vomiting | Number | participants |
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| Diarrhea | Number | participants |
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| Rash | Number | participants |
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| Irritability | Number | participants |
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| Lethargy | Number | participants |
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| Seizure | Number | participants |
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| History of tobacco exposure | Number | participants |
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| Family history of asthma/reactive airway disease | Number | participants |
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| Day-care exposure | Includes patients with a sibling in daycare | Number | participants |
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| Receipt of bronchodilators prior to admission | Number | participants |
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| Receipt of antibiotics prior to admission | Number | participants |
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| Receipt of oral corticosteroids before admission | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Length of Stay in the Hospital | Posted | Median | Inter-Quartile Range | hours | Summarized from admission to hospital discharge |
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| Secondary | Clinical Deterioration Necessitating Transfer to Higher Level of Care | Posted | Number | participants | Summarized from admission to hospital discharge |
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Data on adverse events were collected for the period of the patient's hospital stay as well as documentation of any hospital readmissions within 14 days of discharge from the hospital. No contact with patient families was made after hospital discharge.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Continuous Pulse Oximetry Monitoring | Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen. 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. | 0 | 80 | 0 | 80 | ||
| EG001 | 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. 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. | 0 | 81 | 0 | 81 |
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Our study was not designed or powered to detect differences in ICU transfers.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Russell McCulloh | Children's Mercy Hospital Kansas City | 816-234-3061 | rmcculloh@cmh.edu |
| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Superiority or Other (legacy) |
| Units | Counts |
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