NCT04005911

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2019

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

July 18, 2019

Status Verified

July 1, 2019

Enrollment Period

2 months

First QC Date

June 28, 2019

Last Update Submit

July 15, 2019

Conditions

Hypoxia

Keywords

Post-surgical

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Post-Surgical

Patients who underwent surgery and were admitted to the PACU

Device: Themography

Interventions

ThemographyDEVICE

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.

Post-Surgical

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Robert Thiele, M.D.

CONTACT

434-243-9412rht7w@virginia.edu

Keita Ikeda, Ph.D.

CONTACT

434-924-8621ki2d@virginia.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 28, 2019

First Posted

July 2, 2019

Study Start

April 18, 2019

Primary Completion

July 1, 2019

Study Completion

September 1, 2019

Last Updated

July 18, 2019

Record last verified: 2019-07

Locations

US(1)