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Respiratory DiseaseNCT04407806

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

A study testing Continous Pulse oximeter and Intermittent Pulse oximeter in people with Respiratory Disease and Asthma in Children, run by Corewell Health East at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 months to 14 years
What is being tested?
Continous Pulse oximeter and Intermittent Pulse oximeter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
24 Dec 2020to 2 Jun 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 months to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Beaumont Hospital - Royal Oak

    Royal Oak, Michigan, 48073

Other trials in United States

About this study

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.

Read the 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.

Being tested
Continous Pulse oximeter, Intermittent Pulse oximeter
Keywords
Pulse oximetry, Oxygen saturation, Hypoxia, Blood oxygen level
Medical subject headings
Respiration Disorders, Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continous Pulse oximeterDevice

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

  • Intermittent Pulse oximeterDevice

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

Study groups in NCT04407806
Study groupRoleWhat they receive
Continuous Pulse Oximetry Monitoring of Oxygen SaturationActive comparatorContinuous pulse oximetry to measure oxygen saturation
Receives: Device: Continous Pulse oximeter
Intermittent Pulse Oximetry Monitoring of Oxygen SaturationActive comparatorIntermittent pulse oximetry to measure oxygen saturation, measured every 4 hours
Receives: Device: Intermittent Pulse oximeter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Duration of length of stay, up to 14 days

Secondary outcomes (4)
  1. 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.

    Measured: On day of hospital discharge, up to 14 days

  2. 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

    Measured: On day of hospital discharge, up to 14 days

  3. Frequency of Nurse Responses to Pulse Oximetry Alarms

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

    Measured: Duration of length of stay, up to 14 days

  4. Frequency of Pulse Oximetry Alarms Require Medical Intervention

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

    Measured: Duration of length of stay, up to 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2020
  2. Study start24 Dec 2020
  3. Primary completion1 May 2021
  4. Study completion2 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, Prospective, single-site
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04407806
Sponsor's protocol ID
2020-016
Status last verified
Feb 2022
First submitted
14 Apr 2020
Last updated
10 Mar 2022
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Ernst KD; COMMITTEE ON HOSPITAL CARE. Resources Recommended for the Care of Pediatric Patients in Hospitals. Pediatrics. 2020 Apr;145(4):e20200204. doi: 10.1542/peds.2020-0204. Epub 2020 Mar 23.

    PubMed 32205465
  • Barson, W. J., MD. (2019, September 25). Community-acquired pneumonia in children: Clinical features and diagnosis. Retrieved April 13, 2020, from https://www.uptodate.com/contents/community-acquired-pneumonia-in-children-clinical-features-and-diagnosis?search=pneumonia

  • Jain V, Vashisht R, Yilmaz G, Bhardwaj A. Pneumonia Pathology. 2023 Jul 31. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK526116/

    PubMed 30252372
  • Williams DJ, Zhu Y, Grijalva CG, Self WH, Harrell FE Jr, Reed C, Stockmann C, Arnold SR, Ampofo KK, Anderson EJ, Bramley AM, Wunderink RG, McCullers JA, Pavia AT, Jain S, Edwards KM. Predicting Severe Pneumonia Outcomes in Children. Pediatrics. 2016 Oct;138(4):e20161019. doi: 10.1542/peds.2016-1019.

    PubMed 27688362
  • Gereige RS, Laufer PM. Pneumonia. Pediatr Rev. 2013 Oct;34(10):438-56; quiz 455-6. doi: 10.1542/pir.34-10-438. No abstract available.

    PubMed 24085792
  • Silver AH, Nazif JM. Bronchiolitis. Pediatr Rev. 2019 Nov;40(11):568-576. doi: 10.1542/pir.2018-0260. No abstract available.

    PubMed 31676530
  • Piedra, P. A., MD, & Stark, A. R., MD. (2020, March 9). Bronchiolitis in infants and children: Clinical features and diagnosis. Retrieved April 13, 2020, from https://www.uptodate.com/contents/bronchiolitis-in-infants-and-children-clinical-features-and-diagnosis?search=bronchiolitis

  • Patel SJ, Teach SJ. Asthma. Pediatr Rev. 2019 Nov;40(11):549-567. doi: 10.1542/pir.2018-0282. No abstract available.

    PubMed 31676529
  • Sawicki, G., MD, & Haver, K., MD. (2018, November 16). Asthma in children younger than 12 years: Initial evaluation and diagnosis. Retrieved April 13, 2020, from https://www.uptodate.com/contents/asthma-in-children-younger-than-12-years-initial-evaluation-and-diagnosis?search=asthma

  • Schondelmeyer AC, Jenkins AM, Allison B, Timmons KM, Loechtenfeldt AM, Pope-Smyth ST, Vaughn LM. Factors Influencing Use of Continuous Physiologic Monitors for Hospitalized Pediatric Patients. Hosp Pediatr. 2019 Jun;9(6):423-428. doi: 10.1542/hpeds.2019-0007. Epub 2019 May 1.

    PubMed 31043435

Questions about this trial

What is this clinical trial studying?

A study testing Continous Pulse oximeter and Intermittent Pulse oximeter in people with Respiratory Disease and Asthma in Children, run by Corewell Health East at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Length of Stay, Measured in Days (time frame: Duration of length of stay, up to 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04407806, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022.

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