A Comparison of Temperature Measurement During Living Donor Liver Transplantation

Living Donor Liver Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04943263
• Other study ID #: 20210623
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 13, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2021
• Source: Seoul National University Hospital
• Contact: Seong Mi Yang
• Phone: +82-10-7300-6282
• Email: seongmi.yang[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Living Donor Liver Transplantation

Intervention

Other:
• Tracheal Temperature
Temperature measured from the endotracheal tube compared with the esophageal temperature

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Oneclickmedical Co., Ltd. (Seoul, South Korea)

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Lefrant JY, Muller L, de La Coussaye JE, Benbabaali M, Lebris C, Zeitoun N, Mari C, Saïssi 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. Epub 2003 Feb 8. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Yamakage M, Kawana S, Watanabe H, Namiki A. The utility of tracheal temperature monitoring. Anesth Analg. 1993 Apr;76(4):795-9. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of temperature from the cuff surface of the endotracheal tube and esophageal temperature	temperature	Phase 1 (preanhepatic): 60 minutes after the anesthetic induction
Primary	Comparison of temperature from the cuff surface of the endotracheal tube and esophageal temperature	temperature	Phase 2 (anhepatic 1): 10 minutes after recipient hepatectomy
Primary	Comparison of temperature from the cuff surface of the endotracheal tube and esophageal temperature	temperature	Phase 3 (anhepatic 2): 10 minutes after IVC clamping
Primary	Comparison of temperature from the cuff surface of the endotracheal tube and esophageal temperature	temperature	Phase 4 (Reperfusion): 5 minutes after Reperfusion
Primary	Comparison of temperature from the cuff surface of the endotracheal tube and esophageal temperature	temperature	Phase 5 (neohepatic): 1 hour after Reperfusion
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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