Cardiac DiseaseNCT04160845
Non-invasive Forehead Skin Temperature in Cardiac Surgery
An observational study of Cardiac Disease, run by Konkuk University Medical Center.
Trial summary
This study is to see if the zero-heat-flux (ZHF) thermometry monitoring in cardiac surgery with moderate hypothermic cardiopulmonary bypass differs from Temp-NP, which reflects central body temperature 30 minutes after the end of the cardiac surgery. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- cardiac surgery
- Type of treatment
- Surgery or procedure
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 2 Sep 2020to 30 Nov 2020
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients over 19 years of age who are scheduled to undergo cardiac surgery are expected to apply cardiopulmonary bypass.
Who may be able to join
- 1. Patients over 19 years of age who are scheduled to undergo cardiac surgery are expected to apply cardiopulmonary bypass.
- 2. Patients Signed to Participate in Research
Who cannot join
- 1 Patient who refuses to sign consent form
- 2. Under 19 Criteria for exclusion during research
- In case a patient who decides to participate in a study refuses to make a decision or reverses (rejects) a decision after participation
- Patients who fail to perform Temp-NP surveillance during heart surgery
- Deep hypothermia patients
- Continuing the study is detrimental to the welfare of the study subjects
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Compression of Non-invasive Forehead Skin Temperature to Core Temperature in Cardiac Surgery
This study is to see if the zero-heat-flux (ZHF) thermometry monitoring in cardiac surgery with moderate hypothermic cardiopulmonary bypass differs from Temp-NP, which reflects central body temperature 30 minutes after the end of the cardiac surgery.
Read the detailed description
This study is a single organ, prospective study of patients who are scheduled to perform cardiopulmonary surgery to compare noninvasive skin temperature attached to the forehead with core temperature after cardiopulmonary bypass in cardiac surgery.
anesthesia induction and maintenance use standard systemic anesthesia protocols using propofol-remifentanil-rocurium. Even before inducing anesthesia, it will start monitoring ECGs, noninvasive blood pigmentation, local cerebral oxygen saturation, blood pressure and heart rate.
After anesthesia induction and intraperitoneal intubation, the Temp-NP Hardness Ultrasound and Cardiac Output Monitoring through pulmonary artery catheter are initiated.
Before and after cardiopulmonary bypass, adjust the respiration rate of FiO2 04-0.5 so that the end tidal CO2 is 35-40 mmHg. Apply a positive end-expiratory pressure of 8 mmHg at the end of the period.
For surgery, heparin 3 mg/kg is administered, cardiopulmonary system is operated at medium-low body temperature, cardiopulmonary system is administered, and heart surgery is initiated from a cardiac standstill state. After the heart valve and coronary artery transplantation period, warm up to raise body temperature.
After recovering proper cardiac function, heparin is neutralized by administering 3 mg/kg of protamine and weaning from the cardiopulmonary bypass by administering inotropic agents.
After the anesthesia is finished, the patient is transferred to the intensive care unit in an intubated state, and is kept in isolation with dexmedetomidine until the tube is released.
The temperature monitoring of the sorcery starts the Temp-ZHF monitoring even before the anesthetic induction, and then the Temp-NP and Temp-PAC monitoring after the induction. Temp-NP monitoring devices are removed after surgery, but Temp-ZHF and Temp-PAC monitoring are also maintained in intensive care units after surgery.
The objectives of the study are as follows. primary goal Temp-ZHF vs. Temp-NP 30 minutes after cardiopulmonary bypass. secondary goal
- After 30 minutes of anesthesia flow, there is a comparison between Temp-ZHF and Temp-NP.
- It is compared to Temp-ZHF and Temp-PAC after 30 minutes of anesthesia.
- Compared to Temp-ZHF and Temp-NP 30 minutes after cardiopulmonary bypass.
- Compared to Temp-ZHF and Temp-PAC 30 minutes after cardiopulmonary bypass
- 30 minutes after surgery, compared to Temp-ZHF and Temp-PAC.
- Conditions
- Cardiac Disease
- Being tested
- cardiac surgery
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac surgeryProcedure or surgery
cardiac surgery with hypothermic cardiopulmonary bypass
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of skin temperature and nasopharyngeal temperature
comparison of Temp-ZHF vs. Temp-NP after cardiopulmonary bypass
Measured: 30 minutes after cardiopulmonary bypass
Secondary outcomes (1)
comparison between skin temperature and PA catheter temperature
comparison between Temp-ZHF and Temp-PAC 30 minutes after cardiopulmonary bypass
Measured: 30 minutes after cardiopulmonary bypass
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start2 Sep 2020 (estimated)
- Primary completion30 Nov 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
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 Cardiac 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
- Cross-sectional
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae-Yop Kim, MD PhD, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160845
- Sponsor's protocol ID
- 2019-11-008
- Status last verified
- Aug 2020
- First submitted
- 8 Nov 2019
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Joung KW, Oh CS, Kim JY, Lee S, Lee DK, Kim TY, Choi IC. Zero-heat flux skin temperature tracks nasopharyngeal temperature during cardiac surgery with cardiopulmonary bypass: a prospective observational study. BMC Anesthesiol. 2026 Jul 14. doi: 10.1186/s12871-026-04068-4. Online ahead of print.
PubMed 42449227
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compression of Non-invasive Forehead Skin Temperature to Core Temperature in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04160845
- Acronym / sponsor ID
- 2019-11-008
- Conditions
- Cardiac Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- 2 Sep 2020 (estimated)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 13 Nov 2019 (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.
This study is to see if the zero-heat-flux (ZHF) thermometry monitoring in cardiac surgery with moderate hypothermic cardiopulmonary bypass differs from Temp-NP, which reflects central body temperature 30 minutes after the end of the cardiac surgery.
Detailed description
This study is a single organ, prospective study of patients who are scheduled to perform cardiopulmonary surgery to compare noninvasive skin temperature attached to the forehead with core temperature after cardiopulmonary bypass in cardiac surgery.
anesthesia induction and maintenance use standard systemic anesthesia protocols using propofol-remifentanil-rocurium. Even before inducing anesthesia, it will start monitoring ECGs, noninvasive blood pigmentation, local cerebral oxygen saturation, blood pressure and heart rate.
After anesthesia induction and intraperitoneal intubation, the Temp-NP Hardness Ultrasound and Cardiac Output Monitoring through pulmonary artery catheter are initiated.
Before and after cardiopulmonary bypass, adjust the respiration rate of FiO2 04-0.5 so that the end tidal CO2 is 35-40 mmHg. Apply a positive end-expiratory pressure of 8 mmHg at the end of the period.
For surgery, heparin 3 mg/kg is administered, cardiopulmonary system is operated at medium-low body temperature, cardiopulmonary system is administered, and heart surgery is initiated from a cardiac standstill state. After the heart valve and coronary artery transplantation period, warm up to raise body temperature.
After recovering proper cardiac function, heparin is neutralized by administering 3 mg/kg of protamine and weaning from the cardiopulmonary bypass by administering inotropic agents.
After the anesthesia is finished, the patient is transferred to the intensive care unit in an intubated state, and is kept in isolation with dexmedetomidine until the tube is released.
The temperature monitoring of the sorcery starts the Temp-ZHF monitoring even before the anesthetic induction, and then the Temp-NP and Temp-PAC monitoring after the induction. Temp-NP monitoring devices are removed after surgery, but Temp-ZHF and Temp-PAC monitoring are also maintained in intensive care units after surgery.
The objectives of the study are as follows. primary goal Temp-ZHF vs. Temp-NP 30 minutes after cardiopulmonary bypass. secondary goal
- After 30 minutes of anesthesia flow, there is a comparison between Temp-ZHF and Temp-NP.
- It is compared to Temp-ZHF and Temp-PAC after 30 minutes of anesthesia.
- Compared to Temp-ZHF and Temp-NP 30 minutes after cardiopulmonary bypass.
- Compared to Temp-ZHF and Temp-PAC 30 minutes after cardiopulmonary bypass
- 30 minutes after surgery, compared to Temp-ZHF and Temp-PAC.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 19 years of age who are scheduled to undergo cardiac surgery are expected to apply cardiopulmonary bypass.
Key inclusion criteria (2 listed)
- 1. Patients over 19 years of age who are scheduled to undergo cardiac surgery are expected to apply cardiopulmonary bypass.
- 2. Patients Signed to Participate in Research
Key exclusion criteria (6 listed)
- 1 Patient who refuses to sign consent form
- 2. Under 19 Criteria for exclusion during research
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 |
|---|---|---|
| cardiac surgerycardiac surgery with hypothermic cardiopulmonary bypass | Procedure or surgery | – |
Primary outcome
comparison of skin temperature and nasopharyngeal temperature
Time frame: 30 minutes after cardiopulmonary bypass
comparison of Temp-ZHF vs. Temp-NP after cardiopulmonary bypass
1 secondary outcome
comparison between skin temperature and PA catheter temperature
Time frame: 30 minutes after cardiopulmonary bypass
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Derived from this study: PubMed 42449227Joung KW, Oh CS, Kim JY, Lee S, Lee DK, Kim TY, Choi IC. Zero-heat flux skin temperature tracks nasopharyngeal temperature during cardiac surgery with cardiopulmonary bypass: a prospective observational study. BMC Anesthesiol. 2026 Jul 14. doi: 10.1186/s12871-026-04068-4. Online ahead of print.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Disease, run by Konkuk University Medical Center.
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 2 inclusion and 6 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 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Tae-Yop Kim (0222926942, taeyop@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of skin temperature and nasopharyngeal temperature (time frame: 30 minutes after cardiopulmonary bypass). 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 NCT04160845, 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 13 Aug 2020.