Temperature Monitoring in Cardiac Surgery: Agreement Between Different Clinical Methods

April 29, 2025 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)

48

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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 for each method and averaged using the Bland-Altman method for repeated measures
Agreement between core temperatures obtained in arterial CPB output versus venous inlet of CPB, bladder, pulmonary artery, nasopharynx and forehead (Tcore). The measurements were compared between the different methods using the Bland-Altman method of repeated measures and expressed as mean difference (reference method-alternative method) plus CI95%.
24 temperature measures per patient recorded at 5-min intervals for each method and averaged using the Bland-Altman method for repeated measures

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 7, 2025

Last Update Submitted That Met QC Criteria

April 29, 2025

Last Verified

April 1, 2025

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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