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NCT04005911 Clinical Trial

Non-Contact Respiratory Rate Monitoring

Hypoxia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04005911
Other study ID # 21353
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 18, 2019
Est. completion date September 2019

Study information
Verified date July 2019
Source University of Virginia
Contact Robert Thiele, M.D.
Phone 434-243-9412
Email rht7w@virginia.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date September 2019
Est. primary completion date July 2019
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States University of Virginia Charlottesville Virginia

Sponsors (1)
Lead Sponsor Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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