search
Back to results

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

Primary Purpose

Respiratory Disease, Asthma in Children, Pneumonia in Children

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continous Pulse oximeter
Intermittent Pulse oximeter
Sponsored by
William Beaumont Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Disease focused on measuring Pulse oximetry, Oxygen saturation, Hypoxia, Blood oxygen level

Eligibility Criteria

3 Months - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beaumont Hospital - Royal Oak

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Continuous Pulse Oximetry Monitoring of Oxygen Saturation

Intermittent Pulse Oximetry Monitoring of Oxygen Saturation

Arm Description

Continuous pulse oximetry to measure oxygen saturation

Intermittent pulse oximetry to measure oxygen saturation, measured every 4 hours

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
Frequency of Nurse Responses to Pulse Oximetry Alarms
Number of times nurses respond to pulse oximetry alarms, tabulated per patient
Frequency of Pulse Oximetry Alarms Require Medical Intervention
Number of pulse oximetry alarms requiring intervention by nurses, tabulated per patient

Full Information

First Posted
April 14, 2020
Last Updated
February 15, 2022
Sponsor
William Beaumont Hospitals
search

1. Study Identification

Unique Protocol Identification Number
NCT04407806
Brief Title
Utility of Continuous Pulse Oximetry for Pediatric Patients With Stable Respiratory Illness
Official Title
Utility of Continuous Pulse Oximetry for Pediatric Patients With Stable Respiratory Illness
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
December 24, 2020 (Actual)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
June 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
William Beaumont Hospitals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Disease, Asthma in Children, Pneumonia in Children, Bronchiolitis Acute
Keywords
Pulse oximetry, Oxygen saturation, Hypoxia, Blood oxygen level

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, Prospective, single-site
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous Pulse Oximetry Monitoring of Oxygen Saturation
Arm Type
Active Comparator
Arm Description
Continuous pulse oximetry to measure oxygen saturation
Arm Title
Intermittent Pulse Oximetry Monitoring of Oxygen Saturation
Arm Type
Active Comparator
Arm Description
Intermittent pulse oximetry to measure oxygen saturation, measured every 4 hours
Intervention Type
Device
Intervention Name(s)
Continous Pulse oximeter
Intervention Description
Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation throughout hospitalization
Intervention Type
Device
Intervention Name(s)
Intermittent Pulse oximeter
Intervention Description
Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation intermittently during hospitalization
Primary Outcome Measure Information:
Title
Length of Stay, Measured in Days
Description
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
Secondary Outcome Measure Information:
Title
Comfort of Parents: Level of Care Their Child Received in Hospital
Description
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
Title
Comfort of Parents: Continuing to Care for Their Child at Home
Description
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
Title
Frequency of Nurse Responses to Pulse Oximetry Alarms
Description
Number of times nurses respond to pulse oximetry alarms, tabulated per patient
Time Frame
Duration of length of stay, up to 14 days
Title
Frequency of Pulse Oximetry Alarms Require Medical Intervention
Description
Number of pulse oximetry alarms requiring intervention by nurses, tabulated per patient
Time Frame
Duration of length of stay, up to 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graham Krasan, MD
Organizational Affiliation
Beaumont Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beaumont Hospital - Royal Oak
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32205465
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
30252372
Citation
Jain V, Vashisht R, Yilmaz G, Bhardwaj A. Pneumonia Pathology. 2023 Jul 31. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK526116/
Results Reference
background
PubMed Identifier
27688362
Citation
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.
Results Reference
background
PubMed Identifier
24085792
Citation
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. Erratum In: Pediatr Rev. 2014 Jan;35(1):29. Dosage error in article text.
Results Reference
background
PubMed Identifier
31676530
Citation
Silver AH, Nazif JM. Bronchiolitis. Pediatr Rev. 2019 Nov;40(11):568-576. doi: 10.1542/pir.2018-0260. No abstract available.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
31676529
Citation
Patel SJ, Teach SJ. Asthma. Pediatr Rev. 2019 Nov;40(11):549-567. doi: 10.1542/pir.2018-0282. No abstract available.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
31043435
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs