A Comparison of Temperature Measurement During Living Donor Liver Transplantation

A Comparison of Body Temperature Measured From the Cuff Surface of the Endotracheal Tube and Core Temperature in Living Donor Liver Transplantation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Living Donor Liver Transplantation
• Intervention / Treatment: Other: Tracheal Temperature

Detailed Description

Hypothermia occurs frequently in patients undergoing surgery and is known to be related with many postoperative complications. Patients undergoing living donor liver transplantation are usually monitored using an esophageal stethoscope. However, because patients with liver cirrhosis have the risk of variceal bleeding, placement of an esophageal stethoscope can increase the risk of bleeding.

There have been previous reports that temperature monitoring at the cuff surface of an endotracheal tube is not only safe but also provides accurate and reliable data during mild hypothermia after cardiac arrest.

This study compares the temperature measured from the cuff surface of the endotracheal tube and core temperature measured at the esophagus and additionally core temperature measured by a pulmonary artery catheter. The study participants are intubated with an endotracheal tube that has a temperature sensor at the cuff surface of the tube. The rest of the procedure is done according to Seoul National University Hospital's protocol for liver transplantation: an esophageal stethoscope is placed for temperature monitoring and a central line is placed with a Multi-Access lumen Catheter and a pulmonary artery catheter is placed. The temperature measurements from the endotracheal tube and measurements from the esophageal stethoscope are compared at the following 5 phases: 1. preanhepatic phase, 2. anhepatic phase 1 (recipient hepatectomy - IVC clamping), 3. anhepatic phase 2 (IVC clamping - reperfusion), 4. Reperfusion phase, 5. Neohepatic phase.

• Study Type: Interventional
• Enrollment (Anticipated): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
    • Contact: Seong Mi Yang; Phone Number: 82-10-7300-6282; Email: seongmi.yang@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tracheal Temperature; Intubation done with a temperature sensor located on the cuff surface of the endotracheal tube	Other: Tracheal Temperature; Temperature measured from the endotracheal tube compared with the esophageal temperature

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of temperature from the cuff surface of the endotracheal tube and temperature measured at the pulmonary artery catheter	temperature	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	temperature	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	temperature	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	temperature	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	temperature	Phase 5 (neohepatic): 1 hour after Reperfusion

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Oneclickmedical Co., Ltd. (Seoul, South Korea)

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 13, 2021
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: June 23, 2021
• First Submitted That Met QC Criteria: June 23, 2021
• First Posted (Actual): June 29, 2021

Study Record Updates

• Last Update Posted (Actual): August 10, 2021
• Last Update Submitted That Met QC Criteria: August 9, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: core temperature; esophageal temperature; tracheal temperature
• Other Study ID Numbers: 20210623

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No