Non-Contact Respiratory Rate Monitoring

Evaluation of Non-Contact Respiratory Rate Monitor in Post-Surgical Subjects

The purpose of this study is to compare thermographic estimates of respiratory rate to manual counting (visual inspection) and thoracic impedance-based methods. Thermographic methods rely on detection of temperature changes in the nose and mouth that occur as room temperature air passes through the nose and mouth during ventilation, and may offer a non-invasive means of measuring respiratory rate without requiring any patient contact.

Study Overview

• Status: Unknown
• Conditions: Hypoxia
• Intervention / Treatment: Device: Themography

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Robert Thiele, M.D.; Phone Number: 434-243-9412; Email: rht7w@virginia.edu
• Study Contact Backup: Name: Keita Ikeda, Ph.D.; Phone Number: 434-924-8621; Email: ki2d@virginia.edu

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Recruiting
      • University of Virginia
      • Contact: Robert H Thiele, MD; Phone Number: 434-924-2283; Email: rht7w@virginia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Post-surgical patients in the PACU at the University of Virginia

Description

Inclusion Criteria:

• Underwent surgery at the University of Virginia
• Able to provide verbal consent to participate in the study

Exclusion Criteria:

• Unable to provide verbal consent to participate in the study
• Youth
• Prisoners

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Post-Surgical; Patients who underwent surgery and were admitted to the PACU	Device: Themography; Using a FLIR camera, a thermographic recording will be taken of the patient while breathing. Simultaneously, the research investigator will record the thoracic impedance-based respiratory rate as well as manually count respirations in one minute.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement between manually calculated respiratory rate and thermographic respiratory rate	Agreement between manually calculated respiratory rate and thermographic respiratory rate using the Limits of Agreement approach	5 minutes

Collaborators and Investigators

• Sponsor: University of Virginia

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 18, 2019
• Primary Completion (ANTICIPATED): July 1, 2019
• Study Completion (ANTICIPATED): September 1, 2019

Study Registration Dates

• First Submitted: June 28, 2019
• First Submitted That Met QC Criteria: June 28, 2019
• First Posted (ACTUAL): July 2, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 18, 2019
• Last Update Submitted That Met QC Criteria: July 15, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Post-surgical
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: 21353

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No