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

Unknown

Conditions

Intervention / Treatment

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

Observational

Enrollment (Anticipated)

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

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

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

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

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

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)

September 2, 2020

Primary Completion (ANTICIPATED)

November 30, 2020

Study Completion (ANTICIPATED)

November 30, 2020

Study Registration Dates

First Submitted

November 8, 2019

First Submitted That Met QC Criteria

November 8, 2019

First Posted (ACTUAL)

November 13, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 13, 2020

Last Update Submitted That Met QC Criteria

August 12, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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