Cardiac Surgical Procedures Clinical Trial
Official title:
Comparison of the Accuracy and Precision of a Zero Heat Flux Thermometer (SpotOnTM) Versus Pulmonary Artery Temperature Measurement in Patients Undergoing On-pump Heart Surgery: a Prospective, Multicentre, Observational Study.
NCT number | NCT05737147 |
Other study ID # | 17025426 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 1, 2018 |
Est. completion date | July 1, 2022 |
Verified date | March 2023 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | July 1, 2022 |
Est. primary completion date | October 1, 2020 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Rigshospitalet, Copenhagen University Denmark | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark | Aalborg University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ZHF temperature right side versus PAC temperature. | ZHF temperature measured on the right side of the forehead versus PAC temperature. | Perioperatively | |
Primary | ZHF temperature left side versus PAC temperature. | ZHF temperature measured on the left side of the forehead versus PAC temperature. | Perioperatively | |
Primary | ZHF temperature right side versus ZHF temperature left side | ZHF temperature measured on the right side of the forehead versus ZHF temperature measured on the left side of the forehead | Perioperatively | |
Primary | Bladder temperature versus PAC temperature | Bladder temperature versus PAC temperature | Perioperatively |
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