Intraoperative Body Temperature Measurement Using Infrared Camera: Comparison With Esophageal, and Skin Temperatures

Sponsor
Yonsei University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04964232
Collaborator
(none)
40
1
1
7
5.7

Study Details

Study Description

Brief Summary

"A method of monitoring body temperature during surgery is to measure esophageal temperature using a catheter. Although this method is known as a method to accurately measure core temperature, it is not recommended for local anesthesia patients and requires an invasive procedure that can be used to monitor body temperature non-invasive as it may feel uncomfortable during placement and maintenance management. Various methods have been developed to measure body temperature noninvasive, such as in the mouth, armpits, skin surfaces, and aural canals. However, developed methods can also cause discomfort to patients in that they attach sensors to their skin.

In this study, we use the esophageal temperature measurement method, the skin contact temperature measurement method, and the IR contactless temperature measurement method to simultaneously measure body temperature and to compare the accuracy of body temperature measurement according to each method."

Condition or Disease Intervention/Treatment Phase
  • Device: Infrared Camera
  • Device: Esophageal Temperature Probe
  • Device: Skin temperature probe
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Intraoperative Body Temperature Measurement Using Infrared Camera: Comparison With Esophageal, and Skin Temperatures
Actual Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Sep 1, 2021
Anticipated Study Completion Date :
Sep 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Temperature monitoring group

The core-temperature is simultaneously measured by esophageal body temperature measurement methods, skin surface body temperature measurement methods, and thermal imaging camera.

Device: Infrared Camera
The core-temperature is simultaneously measured by esophageal body temperature measurement methods, skin surface body temperature measurement methods, and thermal imaging camera.

Device: Esophageal Temperature Probe
In patients undergoing general anesthesia, the Esophageal temeperature parameters are measured using an Esophageal probe.

Device: Skin temperature probe
In patients undergoing general anesthesia, the skin spot temeperature parameters are measured using an skin adhesive probe.

Outcome Measures

Primary Outcome Measures

  1. The accuracy of core-temperature measurements [Intraoperative period about 1 hour]

    The accuracy of core-temperature measurements between infrared camera,esophageal probe and skin probe in patients with general anesthesia

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 78 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. An adult who underwent endoscopic/laparotomy Hepatectomy of living donor, Pylorus preserving pancreaticoduodenectomy, Renal allograft, Flexible ureterorenoscopic removal of calculus of upper ureter with regular surgery
Exclusion Criteria:
  1. Subjects at risk of bleeding due to esophageal probe, and past cranial, esophageal varicose veins surgery.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of

Sponsors and Collaborators

  • Yonsei University

Investigators

  • Principal Investigator: Jeongmin Kim, Severance Hospital, Yonsei University Health System

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Yonsei University
ClinicalTrials.gov Identifier:
NCT04964232
Other Study ID Numbers:
  • 1-2020-0083
First Posted:
Jul 16, 2021
Last Update Posted:
Jul 16, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yonsei University

Study Results

No Results Posted as of Jul 16, 2021