Living Donor Liver TransplantationNCT04943263
A Comparison of Temperature Measurement During Living Donor Liver Transplantation
A study testing Tracheal Temperature in people with Living Donor Liver Transplantation, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Living Donor Liver Transplantation
- What is being tested?
- Tracheal Temperature
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Aug 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- routine living donor liver transplantation recipients needing pulmonary artery catheterization who have been informed and given consent
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul
Seong Mi Yang, 82-10-7300-6282, seongmi.yang@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Living Donor Liver Transplantation
- Being tested
- Tracheal Temperature
- Keywords
- core temperature, esophageal temperature, tracheal temperature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracheal TemperatureOther
Temperature measured from the endotracheal tube compared with the esophageal temperature
| Study group | Role | What they receive |
|---|---|---|
| Tracheal Temperature | Experimental | Intubation done with a temperature sensor located on the cuff surface of the endotracheal tube Receives: Other: Tracheal Temperature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of temperature from the cuff surface of the endotracheal tube and esophageal temperature
temperature
Measured: Phase 1 (preanhepatic): 60 minutes after the anesthetic induction
Comparison of temperature from the cuff surface of the endotracheal tube and esophageal temperature
temperature
Measured: Phase 2 (anhepatic 1): 10 minutes after recipient hepatectomy
Comparison of temperature from the cuff surface of the endotracheal tube and esophageal temperature
temperature
Measured: Phase 3 (anhepatic 2): 10 minutes after IVC clamping
Comparison of temperature from the cuff surface of the endotracheal tube and esophageal temperature
temperature
Measured: Phase 4 (Reperfusion): 5 minutes after Reperfusion
Comparison of temperature from the cuff surface of the endotracheal tube and esophageal temperature
temperature
Measured: 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
temperature
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Phase 5 (neohepatic): 1 hour after Reperfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start13 Aug 2021 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Living Donor Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Oneclickmedical Co., Ltd. (Seoul, South Korea)
- Responsible party
- Principal investigator, Hee-Soo Kim, Seoul National University Hospital
- Investigators
- Hee Soo Kim, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943263
- Sponsor's protocol ID
- 20210623
- Status last verified
- Aug 2021
- First submitted
- 23 Jun 2021
- Last updated
- 10 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 9087467Kurz 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.
PubMed 8606715Rajagopalan 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.
PubMed 18156884Sessler 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.
PubMed 26775126Lefrant 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.
PubMed 12577157Erickson 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.
PubMed 8403963Yamakage 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.
PubMed 8466020Torossian 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.
PubMed 19137809Hayes 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.
PubMed 8823651Haugk 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.
PubMed 20495450Sun 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.
PubMed 30205926
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Body Temperature Measured From the Cuff Surface of the Endotracheal Tube and Core Temperature in Living Donor Liver Transplantation
- ClinicalTrials.gov ID
- NCT04943263
- Acronym / sponsor ID
- 20210623
- Conditions
- Living Donor Liver Transplantation
- Keywords
- core temperature, esophageal temperature, tracheal temperature
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Oneclickmedical Co., Ltd. (Seoul, South Korea)
- Study start
- 13 Aug 2021 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 29 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tracheal Temperature | Experimental | Other: Tracheal TemperatureIntubation done with a temperature sensor located on the cuff surface of the endotracheal tube |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- routine living donor liver transplantation recipients needing pulmonary artery catheterization who have been informed and given consent
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tracheal TemperatureTemperature measured from the endotracheal tube compared with the esophageal temperature | Other | Tracheal Temperature |
Primary outcome
Comparison of temperature from the cuff surface of the endotracheal tube and esophageal temperature
Time frame: Phase 1 (preanhepatic): 60 minutes after the anesthetic induction
temperature
Comparison of temperature from the cuff surface of the endotracheal tube and esophageal temperature
Time frame: Phase 2 (anhepatic 1): 10 minutes after recipient hepatectomy
temperature
Comparison of temperature from the cuff surface of the endotracheal tube and esophageal temperature
Time frame: Phase 3 (anhepatic 2): 10 minutes after IVC clamping
temperature
Comparison of temperature from the cuff surface of the endotracheal tube and esophageal temperature
Time frame: Phase 4 (Reperfusion): 5 minutes after Reperfusion
temperature
Comparison of temperature from the cuff surface of the endotracheal tube and esophageal temperature
Time frame: Phase 5 (neohepatic): 1 hour after Reperfusion
temperature
5 secondary outcomes
Comparison of temperature from the cuff surface of the endotracheal tube and temperature measured at the pulmonary artery catheter
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Phase 5 (neohepatic): 1 hour after Reperfusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Background: PubMed 9087467Frank 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.
- Background: PubMed 8606715Kurz 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.
- Background: PubMed 18156884Rajagopalan 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.
- Background: PubMed 26775126Sessler 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.
- Background: PubMed 12577157Lefrant 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.
- Background: PubMed 8403963Erickson 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.
- Background: PubMed 8466020Yamakage 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.
- Background: PubMed 19137809Torossian 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.
- Background: PubMed 8823651Hayes 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.
- Background: PubMed 20495450Haugk 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.
- Background: PubMed 30205926Sun 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hee Soo Kim principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tracheal Temperature in people with Living Donor Liver Transplantation, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seong Mi Yang (+82-10-7300-6282, seongmi.yang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of temperature from the cuff surface of the endotracheal tube and esophageal temperature (time frame: Phase 1 (preanhepatic): 60 minutes after the anesthetic induction). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04943263, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021.