NCT04943263

Brief Summary

The purpose of this study is to compare the temperature measured from the cuff surface of the endotracheal tube and core temperature measured at the esophagus in living donor liver transplantation recipients.

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
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

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

First Submitted

Initial submission to the registry

June 23, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 29, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

August 13, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

August 10, 2021

Status Verified

August 1, 2021

Enrollment Period

11 months

First QC Date

June 23, 2021

Last Update Submit

August 9, 2021

Conditions

Living Donor Liver Transplantation

Keywords

core temperatureesophageal temperaturetracheal temperature

Outcome Measures

Primary Outcomes (5)

  • Comparison of temperature from the cuff surface of the endotracheal tube and esophageal temperature

    temperature

    Phase 1 (preanhepatic): 60 minutes after the anesthetic induction

  • Comparison of temperature from the cuff surface of the endotracheal tube and esophageal temperature

    temperature

    Phase 2 (anhepatic 1): 10 minutes after recipient hepatectomy

  • Comparison of temperature from the cuff surface of the endotracheal tube and esophageal temperature

    temperature

    Phase 3 (anhepatic 2): 10 minutes after IVC clamping

  • Comparison of temperature from the cuff surface of the endotracheal tube and esophageal temperature

    temperature

    Phase 4 (Reperfusion): 5 minutes after Reperfusion

  • Comparison of temperature from the cuff surface of the endotracheal tube and esophageal temperature

    temperature

    Phase 5 (neohepatic): 1 hour after Reperfusion

Secondary Outcomes (5)

  • Comparison of temperature from the cuff surface of the endotracheal tube and temperature measured at the pulmonary artery catheter

    Phase 1 (preanhepatic): 60 minutes after the anesthetic induction

  • Comparison of temperature from the cuff surface of the endotracheal tube and temperature measured at the pulmonary artery catheter

    Phase 2 (anhepatic 1): 10 minutes after recipient hepatectomy

  • Comparison of temperature from the cuff surface of the endotracheal tube and temperature measured at the pulmonary artery catheter

    Phase 3 (anhepatic 2): 10 minutes after IVC clamping

  • Comparison of temperature from the cuff surface of the endotracheal tube and temperature measured at the pulmonary artery catheter

    Phase 4 (Reperfusion): 5 minutes after Reperfusion

  • Comparison of temperature from the cuff surface of the endotracheal tube and temperature measured at the pulmonary artery catheter

    Phase 5 (neohepatic): 1 hour after Reperfusion

Study Arms (1)

Tracheal Temperature

EXPERIMENTAL

Intubation done with a temperature sensor located on the cuff surface of the endotracheal tube

Other: Tracheal Temperature

Interventions

Tracheal TemperatureOTHER

Temperature measured from the endotracheal tube compared with the esophageal temperature

Tracheal Temperature

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • routine living donor liver transplantation recipients needing pulmonary artery catheterization who have been informed and given consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (11)

  • Frank SM, Fleisher LA, Breslow MJ, Higgins MS, Olson KF, Kelly S, Beattie C. Perioperative maintenance of normothermia reduces the incidence of morbid cardiac events. A randomized clinical trial. JAMA. 1997 Apr 9;277(14):1127-34.

    PMID: 9087467BACKGROUND

  • Kurz A, Sessler DI, Lenhardt R. Perioperative normothermia to reduce the incidence of surgical-wound infection and shorten hospitalization. Study of Wound Infection and Temperature Group. N Engl J Med. 1996 May 9;334(19):1209-15. doi: 10.1056/NEJM199605093341901.

    PMID: 8606715BACKGROUND

  • 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

  • Sessler DI. Perioperative thermoregulation and heat balance. Lancet. 2016 Jun 25;387(10038):2655-2664. doi: 10.1016/S0140-6736(15)00981-2. Epub 2016 Jan 8.

    PMID: 26775126BACKGROUND

  • Lefrant JY, Muller L, de La Coussaye JE, Benbabaali M, Lebris C, Zeitoun N, Mari C, Saissi G, Ripart J, Eledjam JJ. Temperature measurement in intensive care patients: comparison of urinary bladder, oesophageal, rectal, axillary, and inguinal methods versus pulmonary artery core method. Intensive Care Med. 2003 Mar;29(3):414-8. doi: 10.1007/s00134-002-1619-5. Epub 2003 Feb 8.

    PMID: 12577157BACKGROUND

  • Erickson RS, Kirklin SK. Comparison of ear-based, bladder, oral, and axillary methods for core temperature measurement. Crit Care Med. 1993 Oct;21(10):1528-34. doi: 10.1097/00003246-199310000-00022.

    PMID: 8403963BACKGROUND

  • Yamakage M, Kawana S, Watanabe H, Namiki A. The utility of tracheal temperature monitoring. Anesth Analg. 1993 Apr;76(4):795-9. doi: 10.1213/00000539-199304000-00020.

    PMID: 8466020BACKGROUND

  • Torossian A. Thermal management during anaesthesia and thermoregulation standards for the prevention of inadvertent perioperative hypothermia. Best Pract Res Clin Anaesthesiol. 2008 Dec;22(4):659-68. doi: 10.1016/j.bpa.2008.07.006.

    PMID: 19137809BACKGROUND

  • Hayes JK, Collette DJ, Peters JL, Smith KW. Monitoring body-core temperature from the trachea: comparison between pulmonary artery, tympanic, esophageal, and rectal temperatures. J Clin Monit. 1996 May;12(3):261-9. doi: 10.1007/BF00857648.

    PMID: 8823651BACKGROUND

  • Haugk M, Stratil P, Sterz F, Krizanac D, Testori C, Uray T, Koller J, Behringer W, Holzer M, Herkner H. Temperature monitored on the cuff surface of an endotracheal tube reflects body temperature. Crit Care Med. 2010 Jul;38(7):1569-73. doi: 10.1097/CCM.0b013e3181e47a20.

    PMID: 20495450BACKGROUND

  • Sun Y, Jia LL, Yu WL, Yu HL, Sheng MW, Du HY. The changes of intraoperative body temperature in adult liver transplantation: A retrospective study. Hepatobiliary Pancreat Dis Int. 2018 Dec;17(6):496-501. doi: 10.1016/j.hbpd.2018.08.006. Epub 2018 Aug 29.

    PMID: 30205926BACKGROUND

Study Officials

  • Hee Soo Kim

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seong Mi Yang

CONTACT

+82-10-7300-6282seongmi.yang@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 23, 2021

First Posted

June 29, 2021

Study Start

August 13, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

August 10, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)