Coronary Artery DiseaseTVPNCT05595616
Comparison of Temperature Using Tracheal Thermometer and Pulmonary Artery Catheter in Adult Patients Undergoing CABG
An observational study of Coronary Artery Disease, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial summary
In anesthesia, monitoring of core body temperature is one of important factors. Measurement of temperature using a pulmonary artery catheter is representative one of core temperature measurements. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Insertion of tracheal thermometer and pulmonary artery catheter
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Sep 2022to 31 Aug 2023
- Phase
- Observational
- 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
Study population: Adult patients over 18-year-old undergoing coronary artery bypass surgery using pulmonary artery catheter
Who may be able to join
- Adult patients over 18-year-old undergoing coronary artery bypass surgery
Who cannot join
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612
About this study
Official title: Comparison of Core Temperature Using Tracheal Thermometer and Pulmonary Artery Catheter in Adult Patients Undergoing Coronary Artery Bypass Graft Surgery
In anesthesia, monitoring of core body temperature is one of important factors. Measurement of temperature using a pulmonary artery catheter is representative one of core temperature measurements. The core temperature by a pulmonary artery catheter is compared with the tracheal temperature by an endotracheal tube with thermometer. This study was designed to confirm the accuracy of the endotracheal tube thermometer.
Read the detailed description
All patients undergoing general anesthesia are monitored core body temperature. Coronary artery bypass graft surgery needs general anesthesia with endotracheal intubation and insertion of pulmonary artery catheter. Using endotracheal tube with thermometer and pulmonary artery catheter, the investigators will measure tracheal temperature and pulmonary artery temperature every 5 minutes for 1 hour after induction of general anesthesia.
Standard monitoring devices (non-invasive BP, electrocardiogram, pulse oxygen saturation) are applied to participants in an operation room, and 1% propofol 1-2 mg/kg and rocuronium 0.8 mg/kg are administered intravenously for induction of general anesthesia. An endotracheal tube with thermometer (Human Endotracheal Tube, Insung Medical Co., Korea) is inserted. After inserting a 9Fr central venous catheter with a pulmonary artery catheter insertion port, core body temperature is measured by a pulmonary artery catheter (Swan-Ganz CCOmbo V, Edwards Lifesciences, Irvine, California, USA).
Tracheal temperature will be compared with pulmonary artery temperature by using Bland-Altman method.
- Conditions
- Coronary Artery Disease
- Being tested
- Insertion of tracheal thermometer and pulmonary artery catheter
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insertion of tracheal thermometer and pulmonary artery catheterDevice
Endotracheal intubation of endotracheal tube with thermometer (Human Endotracheal Tube, Insung Medical Co., Korea) and insertion of Swan-Ganz catheter
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of tracheal temperature versus pulmonary artery temperature
This study compares core body temperature measured by a pulmonary artery catheter and temperature measured by an endotracheal tube with a thermometer.
Additional description> Time points or intervals are not important factors in this study. The study needs repeated measurements using method A (tracheal thermometer) and method B (pulmonary artery thermometer). Then it compares tracheal temperature with pulmonary artery temperature, and checks the agreement of method A and B.
Measured: Tracheal temperature and pulmonary arterial temperature are measured every 5 minutes for 1 hour after induction of general anesthesia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start20 Sep 2022
- Primary completion31 Dec 2022
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Park Seyeon, MD, Pusan National University Yangsan Hospital
- Investigators
- Seyeon Park, MD, Principal investigator, PNUYH, 20 Geumo-ro, Beomeo-ri, Mulgeumeup, 50612, Yangsan, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595616
- Sponsor's protocol ID
- 2022-09-01
- Acronym
- TVP
- Status last verified
- Sep 2023
- First submitted
- 19 Oct 2022
- Last updated
- 8 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Park S, Kim HY, Kim HJ, Jung J, Hong SH, Jung YS, Ha DH, Park DE, Yoon JU. Comparison of core temperature using tracheal thermometer and pulmonary artery catheter in adult patients undergoing coronary artery bypass graft surgery. PLoS One. 2025 Jan 2;20(1):e0314322. doi: 10.1371/journal.pone.0314322. eCollection 2025.
PubMed 39746099
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Core Temperature Using Tracheal Thermometer and Pulmonary Artery Catheter in Adult Patients Undergoing Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT05595616
- Acronym / sponsor ID
- TVP / 2022-09-01
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 27 Oct 2022 (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.
In anesthesia, monitoring of core body temperature is one of important factors. Measurement of temperature using a pulmonary artery catheter is representative one of core temperature measurements. The core temperature by a pulmonary artery catheter is compared with the tracheal temperature by an endotracheal tube with thermometer. This study was designed to confirm the accuracy of the endotracheal tube thermometer.
Detailed description
All patients undergoing general anesthesia are monitored core body temperature. Coronary artery bypass graft surgery needs general anesthesia with endotracheal intubation and insertion of pulmonary artery catheter. Using endotracheal tube with thermometer and pulmonary artery catheter, the investigators will measure tracheal temperature and pulmonary artery temperature every 5 minutes for 1 hour after induction of general anesthesia.
Standard monitoring devices (non-invasive BP, electrocardiogram, pulse oxygen saturation) are applied to participants in an operation room, and 1% propofol 1-2 mg/kg and rocuronium 0.8 mg/kg are administered intravenously for induction of general anesthesia. An endotracheal tube with thermometer (Human Endotracheal Tube, Insung Medical Co., Korea) is inserted. After inserting a 9Fr central venous catheter with a pulmonary artery catheter insertion port, core body temperature is measured by a pulmonary artery catheter (Swan-Ganz CCOmbo V, Edwards Lifesciences, Irvine, California, USA).
Tracheal temperature will be compared with pulmonary artery temperature by using Bland-Altman method.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients over 18-year-old undergoing coronary artery bypass surgery using pulmonary artery catheter
Key inclusion criteria (1 listed)
- Adult patients over 18-year-old undergoing coronary artery bypass surgery
Key exclusion criteria (1 listed)
- Emergency surgery
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 |
|---|---|---|
| Insertion of tracheal thermometer and pulmonary artery catheterEndotracheal intubation of endotracheal tube with thermometer (Human Endotracheal Tube, Insung Medical Co., Korea) and insertion of Swan-Ganz catheter | Device | – |
Primary outcome
Comparison of tracheal temperature versus pulmonary artery temperature
Time frame: Tracheal temperature and pulmonary arterial temperature are measured every 5 minutes for 1 hour after induction of general anesthesia.
This study compares core body temperature measured by a pulmonary artery catheter and temperature measured by an endotracheal tube with a thermometer. Additional description> Time points or intervals are not important factors in this study. The study needs repeated measurements using method A (tracheal thermometer) and method B (pulmonary artery thermometer). Then it compares tracheal temperature with pulmonary artery temperature, and checks the agreement of method A and B.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Derived from this study: PubMed 39746099Park S, Kim HY, Kim HJ, Jung J, Hong SH, Jung YS, Ha DH, Park DE, Yoon JU. Comparison of core temperature using tracheal thermometer and pulmonary artery catheter in adult patients undergoing coronary artery bypass graft surgery. PLoS One. 2025 Jan 2;20(1):e0314322. doi: 10.1371/journal.pone.0314322. eCollection 2025.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
Seyeon Park, MD principal investigator
PNUYH, 20 Geumo-ro, Beomeo-ri, Mulgeumeup, 50612, Yangsan, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Pusan National University Yangsan 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: finished, as of the sponsor's last update on 8 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of tracheal temperature versus pulmonary artery temperature (time frame: Tracheal temperature and pulmonary arterial temperature are measured every 5 minutes for 1 hour after induction of general anesthesia.). 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 NCT05595616, which also lists 1 linked publication.
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 8 Sep 2023.