CompletedNot Applicable

Comparison of the Accuracy and Precision of a Zero Heat Flux Thermometer (SpotOn) Versus Pulmonary Artery Temperature.

Denmark100 participantsStarted 2018-09-01

Plain-language summary

In this study, we aim to compare the core temperature measured with two noninvasive ZHF thermometers and a urinary bladder thermometer against a gold standard blood temperature measured in the pulmonary artery in patients undergoing on-pump cardiac surgery. Additionally we intend to compare the reproducibility of the ZHF measurements by using two devices simultaneously in each patient.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients of both genders scheduled for cardiac surgery with CPB for either coronary artery bypass grafting (CABG), aortic valve replacement (AVR), mitral valve replacement (MVR) or CABG + AVR Exclusion Criteria: * Exclusion criteria if any interruption of skin on the forehead, planned direct heat application to the forehead, or previous cerebral stroke, that might affect the accuracy of the ZHF device

What they're measuring

ZHF temperature right side versus PAC temperature.

Timeframe: Perioperatively

ZHF temperature left side versus PAC temperature.

Timeframe: Perioperatively

ZHF temperature right side versus ZHF temperature left side

Timeframe: Perioperatively

Bladder temperature versus PAC temperature

Timeframe: Perioperatively

Trial details

NCT IDNCT05737147

SponsorRigshospitalet, Denmark

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-10-01

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