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Utility of Continuous Pulse Oximetry for Pediatric Patients With Stable Respiratory Illness

Utility of Continuous Pulse Oximetry for Pediatric Patients With Stable Respiratory Illness

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04407806
Enrollment
6
Registered
2020-05-29
Start date
2020-12-24
Completion date
2021-06-02
Last updated
2022-03-10

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

Conditions

Asthma in Children, Bronchiolitis Acute, Pneumonia in Children, Respiratory Disease

Keywords

Pulse oximetry, Oxygen saturation, Hypoxia, Blood oxygen level

Brief summary

This is a randomized, prospective study to determine if there is a difference in hospital length of stay between patients receiving continuous hardwire cardiorespiratory monitoring and those receiving intermittent vital signs measurements among pediatric patients admitted for uncomplicated respiratory illness.

Detailed description

Respiratory illnesses are among the most common causes for inpatient pediatric hospitalizations every year. The most common respiratory illnesses that make up these hospitalizations include pneumonia, acute bronchiolitis, and asthma. Pneumonia is one of the top three illnesses requiring pediatric hospitalization and is a significant cause or morbidity and mortality. The incidence of pediatric pneumonia varies depending on the country and age group, but worldwide the annual incidence in children younger than five years of age is 150 million and approximately 2 million pediatric deaths, per year, are attributed to pneumonia. Therefore, it is important to understand this disease and how it impacts pediatric hospital admissions. Pneumonia is defined as an acute infection of the lung parenchyma secondary to an infectious etiology such as viruses or bacteria. When an infectious organism is present, the defense mechanisms of the body, including the lungs, are disturbed and the resultant inflammation gives rise to parenchymal damage. Symptoms can include fever, cough, and shortness of breath. Findings on imaging can demonstrate infiltrates in the lungs. Vital sign testing can show elevations in a child's heart rate and decreases in the amount of oxygen present in the blood (pulse oximetry) secondary to the infiltrative processes in the lungs. Pneumonia is the most common serious infection in the pediatric population and accounts for up to 1-4% of all pediatric Emergency Department (ED) visits in the United States (US). Furthermore, of the pediatric patients that present to the ED with pneumonia, 20-25% are admitted to the inpatient pediatric unit for further management. This decision to admit a child to the hospital depends on various underlying factors including age, medical conditions, and severity of illness. One of the factors that is considered when deciding whether to admit a child to the hospital for pneumonia is oxygen saturation, or the amount of oxygen in the blood. Bronchiolitis is another common respiratory illness in the pediatric population and is estimated to account for up to 100,000 US hospital admissions annually. There is a seasonality with most infections occurring in the fall and winter months. It is the leading cause of hospitalization in infants and young children with most cases involving children less than two years of age. Acute bronchiolitis refers to lower airway inflammation and obstruction secondary to a viral infection. When a virus infects the terminal bronchiolar epithelial cells of the lower airways in the lungs, damage to these cells results and subsequently causes cellular sloughing and inflammation. This inflammation, coupled with mucous build-up, accounts for the obstruction that is seen in acute bronchiolitis. Symptoms include rhinitis, congestion, cough, tachypnea, wheezing, and accessory muscle use. Like pneumonia, hypoxemia (decreased oxygen content in the blood) can occur with acute bronchiolitis with the most severe complication being acute respiratory failure requiring mechanical ventilation. The third most common respiratory illness that accounts for pediatric hospital admissions is asthma. Asthma affects 1 in 12 children in the US and is a leading cause of ED visits. It is the most common chronic disease in childhood in developed countries and an estimated 8.3% of children in the US had been diagnosed with asthma in 2016. Asthma is a complex, multifactorial, immune-mediated disease and is defined by episodic and reversible airway constriction and inflammation. Triggers for asthma exacerbations can include infections, environmental allergens, and other irritants. Smooth muscle constriction in the airways and inflammation/edema result in intermittent and reversible lower airway obstructions. Symptoms of asthma include cough, wheezing, shortness of breath, and chest tightness. Like the other respiratory illnesses mentioned, asthma can also result in hypoxemia. Respiratory illnesses, including pneumonia, acute bronchiolitis, and pneumonia pose a significant threat to the pediatric population and are major causes of morbidity and mortality throughout the world. In the US, most pediatric hospital admissions are secondary to these illnesses and determining how to best monitor and manage these patients while in the hospital is important. Specifically, the most ideal technique to monitor for hypoxemia is one of current debate. Currently, there are two main ways to monitor for hypoxemia in a hospital setting. The first is to have a pediatric patient on continuous monitoring, which involves the child being continuously connected to a monitor that displays various vital signs, one of which being oxygen saturation (SpO2). This technique has been studied over the last several years and many concerns have been raised regarding alarm fatigue, or the phenomenon that occurs when a patient is continuously connected to a monitor and the monitor alarms an overwhelming amount. One study found that this form of monitoring was used in up to 50% of children in non-ICU settings and that up to 99% of the alarms did not require clinical action. In fact, this study found that more than 10,000 alarms can occur in a pediatric unit in 1 week and that greater than 150 alarms can occur on any one patient each day. Furthermore, while these continuous monitors are meant to identify patients who are deteriorating, it has been suggested that the efficacy is limited by alarm fatigue and that evidence has not shown them to improve patient outcomes. Finally, a recent study also demonstrated that the second form of monitoring, scheduled vital checks, may be superior to electronic measurements when assessing patients for deterioration. Currently, there are no guidelines to recommend what form of monitoring, continuous monitoring or scheduled vital checks, is superior and studies evaluating the rationale behind widespread continuous monitoring techniques are lacking. This study will determine if there is a difference in hospital length of stay between pediatric patients admitted for uncomplicated respiratory illnesses receiving continuous hardwire cardiorespiratory monitoring and those receiving intermittent vital signs measurements. Patients will be randomized to two groups. One group will be comprised of patients receiving continuous hardwire monitoring during the entire stay in the hospital. The other group will be comprised of patients receiving intermittent vital signs measurements (heart rate, respiratory rate, blood pressure, oxygen saturation, and temperature) every four hours, per standard of care on the pediatric unit. Data will be collected on supplemental oxygen use and patients' level of oxygen saturation throughout the hospital stay. On day of hospital discharge, up to 14 days, parents or guardians will be asked to complete the Parent Study Questionnaire, to assess parental rating of the level of care their child received in hospitalization and parental comfort level with continuing to care for their child at home.

Interventions

DEVICEContinous Pulse oximeter

Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation throughout hospitalization

DEVICEIntermittent Pulse oximeter

Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation intermittently during hospitalization

Sponsors

Corewell Health East
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Randomized, Prospective, single-site

Eligibility

Sex/Gender
ALL
Age
3 Months to 14 Years
Healthy volunteers
No

Inclusion criteria

* Admission for respiratory illness * Corrected gestational age greater than 3 months * Age less than or equal to 14 years old * Admission to Beaumont children's Hospital Pediatric unit, or transfer to pediatric unit from the Beaumont Children's hospital

Exclusion criteria

* Primary admission from non-respiratory illness * Corrected gestational age less than 3 months * Age greater thn 14 years ld * History of chronic lung disease and age less than 1 year * Home oxygen use * Tracheostomy dependent * Neuro-muscular disease of hypotonia secondary to chronic/congenital disease * Cardiac malformation treated with medicatio

Design outcomes

Primary

MeasureTime frameDescription
Length of Stay, Measured in DaysDuration of length of stay, up to 14 daysThe start time for measurement of the length of stay will be when the order for either vitals checks or hardwire monitoring is entered in the computer. The end time for measurement of length of stay will be when the discharge order is entered into the computer system.

Secondary

MeasureTime frameDescription
Comfort of Parents: Level of Care Their Child Received in HospitalOn day of hospital discharge, up to 14 daysParental rating of care received in hospital, as measured by Parent Study Questionnaire,using Likert scale, where 5 represents My child received excellent care and 1 represents My child received very poor care. A higher score represents a better outcome.
Comfort of Parents: Continuing to Care for Their Child at HomeOn day of hospital discharge, up to 14 daysComfort level of parents as measured by Parent Study Questionnaire, using Likert scale where 5 represents very comfortable with continuing to care for child at home and 1 represents very uncomfortable with continuing care for child at home. A higher score represents a better outcome
Frequency of Nurse Responses to Pulse Oximetry AlarmsDuration of length of stay, up to 14 daysNumber of times nurses respond to pulse oximetry alarms, tabulated per patient
Frequency of Pulse Oximetry Alarms Require Medical InterventionDuration of length of stay, up to 14 daysNumber of pulse oximetry alarms requiring intervention by nurses, tabulated per patient

Countries

United States

Participant flow

Participants by arm

ArmCount
Continuous Pulse Oximetry Monitoring of Oxygen Saturation
Continuous pulse oximetry to measure oxygen saturation Continous Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation throughout hospitalization
3
Intermittent Pulse Oximetry Monitoring of Oxygen Saturation
Intermittent pulse oximetry to measure oxygen saturation, measured every 4 hours Intermittent Pulse oximeter: Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation intermittently during hospitalization
3
Total6

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject12

Baseline characteristics

CharacteristicIntermittent Pulse Oximetry Monitoring of Oxygen SaturationTotalContinuous Pulse Oximetry Monitoring of Oxygen Saturation
Age, Continuous1.64 years6.15 years10 years
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
3 participants6 participants3 participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants
Sex: Female, Male
Male
3 Participants6 Participants3 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 30 / 3
other
Total, other adverse events
0 / 30 / 3
serious
Total, serious adverse events
0 / 30 / 3

Outcome results

Primary

Length of Stay, Measured in Days

The start time for measurement of the length of stay will be when the order for either vitals checks or hardwire monitoring is entered in the computer. The end time for measurement of length of stay will be when the discharge order is entered into the computer system.

Time frame: Duration of length of stay, up to 14 days

ArmMeasureValue (MEAN)Dispersion
Continuous Pulse Oximetry Monitoring of Oxygen SaturationLength of Stay, Measured in Days1.15 daysStandard Deviation 0.2
Intermittent Pulse Oximetry Monitoring of Oxygen SaturationLength of Stay, Measured in Days1.04 daysStandard Deviation 0.54
Secondary

Comfort of Parents: Continuing to Care for Their Child at Home

Comfort level of parents as measured by Parent Study Questionnaire, using Likert scale where 5 represents very comfortable with continuing to care for child at home and 1 represents very uncomfortable with continuing care for child at home. A higher score represents a better outcome

Time frame: On day of hospital discharge, up to 14 days

Population: Only 3 participants' parents completed the survey. Only 3 participants data was analyzed for this secondary outcome measure (2 continuous pulse oximetry monitoring participants and 1 intermittent pulse oximetry participant). Parents were not considered enrolled but did contribute to this assessment.

ArmMeasureValue (MEAN)
Continuous Pulse Oximetry Monitoring of Oxygen SaturationComfort of Parents: Continuing to Care for Their Child at Home5 score on a scale
Intermittent Pulse Oximetry Monitoring of Oxygen SaturationComfort of Parents: Continuing to Care for Their Child at Home3 score on a scale
Secondary

Comfort of Parents: Level of Care Their Child Received in Hospital

Parental rating of care received in hospital, as measured by Parent Study Questionnaire,using Likert scale, where 5 represents My child received excellent care and 1 represents My child received very poor care. A higher score represents a better outcome.

Time frame: On day of hospital discharge, up to 14 days

Population: Only 3 participants' parents completed the survey. Only 3 participants data was analyzed for this secondary outcome measure (2 continuous pulse oximetry monitoring participants and 1 intermittent pulse oximetry participant). Parents were not considered enrolled but did contribute to this assessment. Parents were not considered enrolled but did contribute to this assessment.

ArmMeasureValue (MEAN)
Continuous Pulse Oximetry Monitoring of Oxygen SaturationComfort of Parents: Level of Care Their Child Received in Hospital5 score on a scale
Intermittent Pulse Oximetry Monitoring of Oxygen SaturationComfort of Parents: Level of Care Their Child Received in Hospital5 score on a scale
Secondary

Frequency of Nurse Responses to Pulse Oximetry Alarms

Number of times nurses respond to pulse oximetry alarms, tabulated per patient

Time frame: Duration of length of stay, up to 14 days

Population: Data was not collected, data was not analyzed for any participants.

Secondary

Frequency of Pulse Oximetry Alarms Require Medical Intervention

Number of pulse oximetry alarms requiring intervention by nurses, tabulated per patient

Time frame: Duration of length of stay, up to 14 days

Population: Data was not collected, data was not analyzed for any participants.

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