NCT04160845

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 13, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

September 2, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

August 13, 2020

Status Verified

August 1, 2020

Enrollment Period

3 months

First QC Date

November 8, 2019

Last Update Submit

August 12, 2020

Conditions

Cardiac Disease

Outcome Measures

Primary Outcomes (1)

  • comparison of skin temperature and nasopharyngeal temperature

    comparison of Temp-ZHF vs. Temp-NP after cardiopulmonary bypass

    30 minutes after cardiopulmonary bypass

Secondary Outcomes (1)

  • comparison between skin temperature and PA catheter temperature

    30 minutes after cardiopulmonary bypass

Interventions

cardiac surgeryPROCEDURE

cardiac surgery with hypothermic cardiopulmonary bypass

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \. Patients over 19 years of age who are scheduled to undergo cardiac surgery are expected to apply cardiopulmonary bypass.
  • \. Patients Signed to Participate in Research

You may not qualify if:

  • Patient who refuses to sign consent form
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Diseases

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Central Study Contacts

Tae-Yop Kim

CONTACT

0222926942taeyop@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Anesthesiology

Study Record Dates

First Submitted

November 8, 2019

First Posted

November 13, 2019

Study Start

September 2, 2020

Primary Completion

November 30, 2020

Study Completion

November 30, 2020

Last Updated

August 13, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share