Clinical trial NCT04943263: A Comparison of Temperature Measurement During Living Donor Liver Transplantation
Official title: A Comparison of Body Temperature Measured From the Cuff Surface of the Endotracheal Tube and Core Temperature in Living Donor Liver Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Living Donor Liver Transplantation
Keywords: core temperature
esophageal temperature
tracheal temperature
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Oneclickmedical Co., Ltd. (Seoul, South Korea)
First posted: 2021-06-29
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Comparison of temperature from the cuff surface of the endotracheal tube and esophageal temperature
timeFrame: Phase 1 (preanhepatic): 60 minutes after the anesthetic induction
measure: Comparison of temperature from the cuff surface of the endotracheal tube and esophageal temperature
timeFrame: Phase 2 (anhepatic 1): 10 minutes after recipient hepatectomy
measure: Comparison of temperature from the cuff surface of the endotracheal tube and esophageal temperature
timeFrame: Phase 3 (anhepatic 2): 10 minutes after IVC clamping
measure: Comparison of temperature from the cuff surface of the endotracheal tube and esophageal temperature
timeFrame: Phase 4 (Reperfusion): 5 minutes after Reperfusion
measure: Comparison of temperature from the cuff surface of the endotracheal tube and esophageal temperature
timeFrame: Phase 5 (neohepatic): 1 hour after Reperfusion
Secondary outcomes:
measure: Comparison of temperature from the cuff surface of the endotracheal tube and temperature measured at the pulmonary artery catheter
timeFrame: Phase 1 (preanhepatic): 60 minutes after the anesthetic induction
measure: Comparison of temperature from the cuff surface of the endotracheal tube and temperature measured at the pulmonary artery catheter
timeFrame: Phase 2 (anhepatic 1): 10 minutes after recipient hepatectomy
measure: Comparison of temperature from the cuff surface of the endotracheal tube and temperature measured at the pulmonary artery catheter
timeFrame: Phase 3 (anhepatic 2): 10 minutes after IVC clamping
measure: Comparison of temperature from the cuff surface of the endotracheal tube and temperature measured at the pulmonary artery catheter
timeFrame: Phase 4 (Reperfusion): 5 minutes after Reperfusion
measure: Comparison of temperature from the cuff surface of the endotracheal tube and temperature measured at the pulmonary artery catheter
timeFrame: Phase 5 (neohepatic): 1 hour after Reperfusion
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hee Soo Kim
role: PRINCIPAL_INVESTIGATOR
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