NCT04964232

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."

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

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

February 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 16, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

July 16, 2021

Status Verified

July 1, 2021

Enrollment Period

7 months

First QC Date

July 1, 2021

Last Update Submit

July 15, 2021

Conditions

Keywords

core-temperaturenon-contact temperature measurement

Outcome Measures

Primary Outcomes (1)

  • The accuracy of core-temperature measurements

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

    Intraoperative period about 1 hour

Study Arms (1)

Temperature monitoring group

EXPERIMENTAL

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

Device: Infrared CameraDevice: Esophageal Temperature ProbeDevice: Skin temperature probe

Interventions

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

Temperature monitoring group

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

Temperature monitoring group

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

Temperature monitoring group

Eligibility Criteria

Age19 Years - 78 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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

You may not qualify if:

  • \. Subjects at risk of bleeding due to esophageal probe, and past cranial, esophageal varicose veins surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital, Yonsei University Health System

Seoul, South Korea

RECRUITING

Related Publications (13)

  • Sessler DI, Schroeder M, Merrifield B, Matsukawa T, Cheng C. Optimal duration and temperature of prewarming. Anesthesiology. 1995 Mar;82(3):674-81. doi: 10.1097/00000542-199503000-00009.

    PMID: 7879936BACKGROUND
  • Hannenberg AA, Sessler DI. Improving perioperative temperature management. Anesth Analg. 2008 Nov;107(5):1454-7. doi: 10.1213/ane.0b013e318181f6f2. No abstract available.

    PMID: 18931198BACKGROUND
  • Wolberg AS, Meng ZH, Monroe DM 3rd, Hoffman M. A systematic evaluation of the effect of temperature on coagulation enzyme activity and platelet function. J Trauma. 2004 Jun;56(6):1221-8. doi: 10.1097/01.ta.0000064328.97941.fc.

    PMID: 15211129BACKGROUND
  • Boggan WO, Meyer JS. Effects of serotonergic drugs on methaqualone-induced hypothermia. Res Commun Chem Pathol Pharmacol. 1977 Apr;16(4):629-36.

    PMID: 140451BACKGROUND
  • Langesaeter E. Is it more informative to focus on cardiac output than blood pressure during spinal anesthesia for cesarean delivery in women with severe preeclampsia? Anesthesiology. 2008 May;108(5):771-2. doi: 10.1097/ALN.0b013e31816bbe04. No abstract available.

    PMID: 18431110BACKGROUND
  • Rajagopalan S, Mascha E, Na J, Sessler DI. The effects of mild perioperative hypothermia on blood loss and transfusion requirement. Anesthesiology. 2008 Jan;108(1):71-7. doi: 10.1097/01.anes.0000296719.73450.52.

    PMID: 18156884BACKGROUND
  • Poveda VB, Nascimento AS. Intraoperative body temperature control: esophageal thermometer versus infrared tympanic thermometer. Rev Esc Enferm USP. 2016 Nov-Dec;50(6):946-952. doi: 10.1590/S0080-623420160000700010. English, Portuguese.

    PMID: 28198959BACKGROUND
  • Callanan D. Detecting fever in young infants: reliability of perceived, pacifier, and temporal artery temperatures in infants younger than 3 months of age. Pediatr Emerg Care. 2003 Aug;19(4):240-3. doi: 10.1097/01.pec.0000086231.54586.15.

    PMID: 12972820BACKGROUND
  • Morley CJ, Hewson PH, Thornton AJ, Cole TJ. Axillary and rectal temperature measurements in infants. Arch Dis Child. 1992 Jan;67(1):122-5. doi: 10.1136/adc.67.1.122.

    PMID: 1739325BACKGROUND
  • Muma BK, Treloar DJ, Wurmlinger K, Peterson E, Vitae A. Comparison of rectal, axillary, and tympanic membrane temperatures in infants and young children. Ann Emerg Med. 1991 Jan;20(1):41-4. doi: 10.1016/s0196-0644(05)81116-3.

    PMID: 1984726BACKGROUND
  • Cattaneo CG, Frank SM, Hesel TW, El-Rahmany HK, Kim LJ, Tran KM. The accuracy and precision of body temperature monitoring methods during regional and general anesthesia. Anesth Analg. 2000 Apr;90(4):938-45. doi: 10.1097/00000539-200004000-00030.

    PMID: 10735803BACKGROUND
  • Jean-Mary MB, Dicanzio J, Shaw J, Bernstein HH. Limited accuracy and reliability of infrared axillary and aural thermometers in a pediatric outpatient population. J Pediatr. 2002 Nov;141(5):671-6. doi: 10.1067/mpd.2002.127664.

    PMID: 12410196BACKGROUND
  • Negishi T, Abe S, Matsui T, Liu H, Kurosawa M, Kirimoto T, Sun G. Contactless Vital Signs Measurement System Using RGB-Thermal Image Sensors and Its Clinical Screening Test on Patients with Seasonal Influenza. Sensors (Basel). 2020 Apr 13;20(8):2171. doi: 10.3390/s20082171.

    PMID: 32294973BACKGROUND

Study Officials

  • Jeongmin Kim

    Severance Hospital, Yonsei University Health System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2021

First Posted

July 16, 2021

Study Start

February 1, 2021

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

July 16, 2021

Record last verified: 2021-07

Locations