Non-invasive Forehead Skin Temperature in Cardiac Surgery

August 12, 2020 updated by: Tae-Yop Kim, MD PhD, Konkuk University Medical Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

  1. After 30 minutes of anesthesia flow, there is a comparison between Temp-ZHF and Temp-NP.
  2. It is compared to Temp-ZHF and Temp-PAC after 30 minutes of anesthesia.
  3. Compared to Temp-ZHF and Temp-NP 30 minutes after cardiopulmonary bypass.
  4. Compared to Temp-ZHF and Temp-PAC 30 minutes after cardiopulmonary bypass
  5. 30 minutes after surgery, compared to Temp-ZHF and Temp-PAC.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients over 19 years of age who are scheduled to undergo cardiac surgery are expected to apply cardiopulmonary bypass.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 1 Patient who refuses to sign consent form

  • 2. Under 19 Criteria for exclusion during research

    1. In case a patient who decides to participate in a study refuses to make a decision or reverses (rejects) a decision after participation
    2. Patients who fail to perform Temp-NP surveillance during heart surgery
    3. Deep hypothermia patients
    4. Continuing the study is detrimental to the welfare of the study subjects

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
comparison of skin temperature and nasopharyngeal temperature
Time Frame: 30 minutes after cardiopulmonary bypass
comparison of Temp-ZHF vs. Temp-NP after cardiopulmonary bypass
30 minutes after cardiopulmonary bypass

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
comparison between skin temperature and PA catheter temperature
Time Frame: 30 minutes after cardiopulmonary bypass
comparison between Temp-ZHF and Temp-PAC 30 minutes after cardiopulmonary bypass
30 minutes after cardiopulmonary bypass

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Konkuk University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 2, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-11-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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