Temperature Change, BodyNCT04355013

Temperature Monitoring in Cardiac Surgery: Agreement Between Different Clinical Methods

An observational study of Temperature Change, Body, run by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Temperature Change, Body
What is being tested?: Core emperature monitoring
Type of treatment: Medical device
How many people: 48 participants
Where: 1 siteSpain
Study dates: 28 Sep 2016to 22 Nov 2017
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients undergoing cardiac surgery under cardiovascular bypass

Who may be able to join

Only patients requiring a pulmonary artery catheter were included.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

IBSAL
Salamanca, 37007

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Conditions: Temperature Change, Body
Being tested: Core emperature monitoring
Keywords: Core temperature, Cardiac surgery
Medical subject headings: Body Temperature Changes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Core emperature monitoringDevice
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

What is being measured

The primary outcome is the main question the study is designed to answer.

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%.
Measured: 24 temperature measures per patient recorded at 5-min intervals for each method and averaged using the Bland-Altman method for repeated measures

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Sep 201622 Nov 2017

First posted21 Apr 2020
Study start28 Sep 2016
Primary completion22 Nov 2017
Study completion22 Nov 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Temperature Change, BodyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case crossover
Time perspective: Prospective
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04355013
Sponsor's protocol ID: CAUSA27/04/2016
Status last verified: Apr 2025
First submitted: 17 Apr 2020
Last updated: 7 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 35133212

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Temperature Monitoring in Cardiac Surgery: Clinical Study of Agreement Between Different Measurement Methods
ClinicalTrials.gov ID: NCT04355013
Acronym / sponsor ID: CAUSA27/04/2016
Conditions: Temperature Change, Body
Keywords: Core temperature, Cardiac surgery
Study type: Observational
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y LeónUniversity, hospital or other
Study start: 28 Sep 2016
Primary completion: 22 Nov 2017 (actual)
Study completion: 22 Nov 2017 (actual)
First posted: 21 Apr 2020 (actual)
Results: Posted 17 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Observational model: Case crossover
Time perspective: Prospective

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients undergoing cardiac surgery under cardiovascular bypass

Key inclusion criteria (1 listed)

Only patients requiring a pulmonary artery catheter were included.

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Core emperature monitoringMonitoring 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	Device	–

Primary outcome

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%.

Results and safety

Results posted to the registry on 17 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients Undergoing CPB Cardiac Surgery.	48	48

Primary outcome: 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. Median (95% Confidence Interval). Unit: celsius degrees (mean difference)

Measure	Arterial Outlet n = 48	Nasopharyngeal n = 48	Bladder n = 48	Tcore n = 48	Venous Inflow n = 48
Value	35.0 (34.9 to 35.0)	35.2 (35.1 to 35.3)	35.6 (35.5 to 35.6)	34.8 (34.7 to 35.0)	34.8 (34.7 to 34.9)

Arterial Outlet vs Nasopharyngeal: Bland-Altman for repeated measures: -0.16 (95% CI -1.10 to 0.77)
Arterial Outlet vs Venous Inflow: Mean Difference (Final Values): 0.16 (95% CI -0.63 to 0.95), Bland-Altman
Arterial Outlet vs Bladder: Mean Difference (Final Values): -0.62 (95% CI -1.98 to 0.74), Bland-Altman

Adverse events

Time frame: No adverse effects were measured. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
No Adverse Effects Were Measured	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 35133212Sastre 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Temperature Change, Body, run by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04355013, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.