A Comparison of Temperature Measurement During Living Donor Liver Transplantation

NCT ID: NCT04943263

Last Updated: 2021-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-13

Study Completion Date

2022-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Living Donor Liver Transplantation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Tracheal Temperature

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

Group Type EXPERIMENTAL

Tracheal Temperature

Intervention Type OTHER

Temperature measured from the endotracheal tube compared with the esophageal temperature

Interventions

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Tracheal Temperature

Temperature measured from the endotracheal tube compared with the esophageal temperature

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oneclickmedical Co., Ltd. (Seoul, South Korea)

UNKNOWN

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hee-Soo Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hee Soo Kim

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Seong Mi Yang

Role: CONTACT

+82-10-7300-6282

Facility Contacts

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Seong Mi Yang

Role: primary

82-10-7300-6282

References

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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.

Reference Type BACKGROUND
PMID: 9087467 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8606715 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18156884 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26775126 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12577157 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8403963 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8466020 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19137809 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8823651 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20495450 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30205926 (View on PubMed)

Other Identifiers

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20210623

Identifier Type: -

Identifier Source: org_study_id

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