Temperature Monitoring in Cardiac Surgery: Agreement Between Different Clinical Methods
1 other identifier
observational
48
1 country
1
Brief Summary
Observational study to compare core temperatures obtained by 6 methods in patients undergoing cardiac surgery under cardiopulmonary bypass.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2016
1 active site
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
Study Start
First participant enrolled
September 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 22, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 22, 2017
CompletedFirst Submitted
Initial submission to the registry
April 17, 2020
CompletedFirst Posted
Study publicly available on registry
April 21, 2020
CompletedResults Posted
Study results publicly available
October 17, 2024
CompletedMay 7, 2025
April 1, 2025
1.2 years
April 17, 2020
June 10, 2022
April 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Agreement Between Different Core Temperature Methods
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
Interventions
Monitoring core temperatures with probes placed in the arterial outlet and venous inlet of extracorporeal pump, pulmonary artery, bladder, nasopharinx and forehead using a doublé-sensor probe
Eligibility Criteria
Patients undergoing cardiac surgery under cardiovascular bypass
You may qualify if:
- Only patients requiring a pulmonary artery catheter were included.
You may not qualify if:
- Sepsis or previous fever.
- Previous bladder catheter without termistor
- Deep hypothermic circulatory arrest.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IBSAL
Salamanca, 37007, Spain
Related Publications (1)
Sastre JA, Lopez T, Moreno-Rodriguez MA, Reta-Ajo L, Rubia-Martin MC, Diez-Castro R. Reliability of different body temperature measurement sites during normothermic cardiac surgery. Perfusion. 2023 Apr;38(3):580-590. doi: 10.1177/02676591211069918. Epub 2022 Feb 8.
PMID: 35133212RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. José A. Sastre
- Organization
- University Hospital of Salamanca
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
April 17, 2020
First Posted
April 21, 2020
Study Start
September 28, 2016
Primary Completion
November 22, 2017
Study Completion
November 22, 2017
Last Updated
May 7, 2025
Results First Posted
October 17, 2024
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share