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Intermittent Versus Continuous Pulse Oximetry Monitoring of Infants Admitted for Bronchiolitis

Intermittent Versus Continuous Pulse Oximetry Monitoring of Infants Admitted for Bronchiolitis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01014910
Enrollment
161
Registered
2009-11-17
Start date
2009-12-31
Completion date
2014-09-30
Last updated
2021-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiolitis, Hypoxia

Keywords

Bronchiolitis, Hypoxia, Pulse, Oximetry, Hospitalized

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.

Interventions

OTHERContinuous 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.

DEVICEIntermittent 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.

Sponsors

Baylor University
CollaboratorOTHER
Lifespan
CollaboratorOTHER
University of Missouri, Kansas City
CollaboratorOTHER
Children's Mercy Hospital Kansas City
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 24 Months
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

Design outcomes

Primary

MeasureTime frame
Length of Stay in the HospitalSummarized from admission to hospital discharge

Secondary

MeasureTime frame
Clinical Deterioration Necessitating Transfer to Higher Level of CareSummarized from admission to hospital discharge

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

ArmCount
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.
80
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.
81
Total161

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject02

Baseline characteristics

CharacteristicContinuous Pulse Oximetry MonitoringTotalIntermittent Pulse Oximetry Monitoring
Age, Continuous0.22 years0.25 years0.30 years
Day-care exposure8 participants23 participants15 participants
Decreased oral intake51 participants105 participants54 participants
Diarrhea14 participants28 participants14 participants
Family history of asthma/reactive airway disease30 participants75 participants45 participants
History of tobacco exposure17 participants39 participants22 participants
Irritability29 participants56 participants27 participants
Lethargy12 participants23 participants11 participants
Presence of rhonorrhea77 participants154 participants77 participants
Rash6 participants20 participants14 participants
Receipt of antibiotics prior to admission10 participants31 participants21 participants
Receipt of bronchodilators prior to admission58 participants121 participants63 participants
Receipt of oral corticosteroids before admission4 participants16 participants12 participants
Region of Enrollment
United States
80 participants161 participants81 participants
Seizure0 participants0 participants0 participants
Sex: Female, Male
Female
41 Participants73 Participants32 Participants
Sex: Female, Male
Male
39 Participants88 Participants49 Participants
Vomiting32 participants72 participants40 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 800 / 81
serious
Total, serious adverse events
0 / 800 / 81

Outcome results

Primary

Length of Stay in the Hospital

Time frame: Summarized from admission to hospital discharge

ArmMeasureValue (MEDIAN)
Continuous Pulse Oximetry MonitoringLength of Stay in the Hospital38.7 hours
Intermittent Pulse Oximetry MonitoringLength of Stay in the Hospital39.5 hours
Comparison: Differences in LOS were compared between study arms using the Mann-Whitney U-test and the Kaplan-Meier method. Statistical analyses were performed using Stata version 13.1 for Windows (StataCorp). All patients enrolled in the study, including those who subsequently had consent for the intervention withdrawn, were included for analysis (intention to treat).p-value: <0.05Wilcoxon (Mann-Whitney)
Secondary

Clinical Deterioration Necessitating Transfer to Higher Level of Care

Time frame: Summarized from admission to hospital discharge

ArmMeasureValue (NUMBER)
Continuous Pulse Oximetry MonitoringClinical Deterioration Necessitating Transfer to Higher Level of Care4 participants
Intermittent Pulse Oximetry MonitoringClinical Deterioration Necessitating Transfer to Higher Level of Care4 participants
Comparison: The proportion of patients transferred to the intensive care unit in each study arm was compared between study arms using the Pearson χ2 test. All patients enrolled in the study, including those who subsequently had consent for the intervention withdrawn, were included for analysis (intention to treat).p-value: 0.05Chi-squared, Corrected

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026