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

NCT04407806 | Completed Results FDA Device

• 1 other identifier: 2020-016
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Pulse oximetry; Oxygen saturation; Hypoxia; Blood oxygen level

Outcome Measures

Primary Outcomes (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.

  Duration of length of stay, up to 14 days

Secondary Outcomes (4)

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

  On day of hospital discharge, up to 14 days

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

  On day of hospital discharge, up to 14 days

• Frequency of Nurse Responses to Pulse Oximetry Alarms

  Duration of length of stay, up to 14 days

• Frequency of Pulse Oximetry Alarms Require Medical Intervention

  Duration of length of stay, up to 14 days

Study Arms (2)

Continuous Pulse Oximetry Monitoring of Oxygen Saturation

ACTIVE COMPARATOR

Continuous pulse oximetry to measure oxygen saturation

Device: Continous Pulse oximeter

Intermittent Pulse Oximetry Monitoring of Oxygen Saturation

ACTIVE COMPARATOR

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

Device: Intermittent Pulse oximeter

Interventions

Continous Pulse oximeter DEVICE

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

Continuous Pulse Oximetry Monitoring of Oxygen Saturation

Intermittent Pulse oximeter DEVICE

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

Intermittent Pulse Oximetry Monitoring of Oxygen Saturation

Eligibility Criteria

• Age: 3 Months - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

Beaumont Hospital - Royal Oak

Royal Oak, Michigan, 48073, United States

Location

Related Publications (10)

• 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.

  PMID: 32205465 BACKGROUND

• 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

  BACKGROUND

• Jain V, Vashisht R, Yilmaz G, Bhardwaj A. Pneumonia Pathology. 2023 Jul 31. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK526116/

  PMID: 30252372 BACKGROUND

• 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.

  PMID: 27688362 BACKGROUND

• 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.

  PMID: 24085792 BACKGROUND

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

  PMID: 31676530 BACKGROUND

• 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

  BACKGROUND

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

  PMID: 31676529 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 31043435 BACKGROUND

MeSH Terms

Conditions

Respiration Disorders; Hypoxia

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study is limited by low patient enrollment during the study period due to the COVID-19 pandemic restrictions and low hospital admission rates for community acquired respiratory illnesses.

Results Point of Contact

• Title: Dr. Graham Krasan, Pediatric Infectious Disease Specialist
• Organization: William Beaumont Hospital

graham.krasan@beaumont.org

248-551-0046

Study Officials

• Graham Krasan, MD

  Beaumont Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Pediatrician, Infectious Disease Specialty

Model Details: Randomized, Prospective, single-site

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: May 29, 2020
• Study Start: December 24, 2020
• Primary Completion: May 1, 2021
• Study Completion: June 2, 2021
• Last Updated: March 10, 2022
• Results First Posted: March 10, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)