Temperature Monitoring in Cardiac Surgery: Agreement Between Different Clinical Methods

January 21, 2021 updated by: Jose Alfonso Sastre, Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

Temperature Monitoring in Cardiac Surgery: Clinical Study of Agreement Between Different Measurement Methods

Observational study to compare core temperatures obtained by 6 methods in patients undergoing cardiac surgery under cardiopulmonary bypass.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study compares the core temperatures obtained by means of different probes placed in nasopharinx, pulmonary artery, arterial outlet, venous inlet, bladder and forehead in patients undergoing cardiac surgery under cardiopulmonary bypass.

Study Type

Observational

Enrollment (Actual)

304

Contacts and Locations

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

Study Locations

  • Spain
      • Salamanca, Spain, 37007
        • IBSAL

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing cardiac surgery under cardiovascular bypass

Description

Inclusion Criteria:

  • Only patients requiring a pulmonary artery catheter were included.

Exclusion Criteria:

  • Sepsis or previous fever.
  • Previous bladder catheter without termistor
  • Deep hypothermic circulatory arrest.

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
Agreement between different core temperature methods
Time Frame: 24 temperature measures per patient recorded at 5-min intervals during surgery (8 readings in the pre-CPB period, 8 during the CPB period and 8 aftr CPB period)
Agreement between core temperatures obtained in arterial output and venous inlet of CPB, bladder, pulmonary artery, nasopharinx and forehead (Tcore)
24 temperature measures per patient recorded at 5-min intervals during surgery (8 readings in the pre-CPB period, 8 during the CPB period and 8 aftr CPB period)

Collaborators and Investigators

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

Sponsor

Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

Collaborators

Instituto de Investigación Biomédica de Salamanca

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

September 28, 2016

Primary Completion (Actual)

November 22, 2017

Study Completion (Actual)

November 22, 2017

Study Registration Dates

First Submitted

April 17, 2020

First Submitted That Met QC Criteria

April 20, 2020

First Posted (Actual)

April 21, 2020

Study Record Updates

Last Update Posted (Actual)

January 25, 2021

Last Update Submitted That Met QC Criteria

January 21, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAUSA27/04/2016

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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