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

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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05737147
Enrollment
100
Registered
2023-02-21
Start date
2018-09-01
Completion date
2022-07-01
Last updated
2023-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgical Procedures, Temperature Monitoring

Keywords

Thermometers, Thoracic surgery, Perioperative monitoring, Temperature monitoring, Anesthesia, Body temperature, Cardiac surgical procedures

Brief 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.

Detailed description

Anesthesia will be induced with fentanyl, propofol and rocuronium and maintained with sevoflurane and fentanyl or sevoflurane and remifentanil infusion. Hypotension after induction of anesthesia will be treated primarily with phenylephrine or ephedrine and secondarily with norepinephrine infusion. After induction of anesthesia a PAC (Edwards Lifescience, Thermodilution Paceport Catheter 931F75, 7.5F (2.5 mm) 110 cm) will be inserted in the pulmonary artery and connected to a Vigilance 2-monitor. Core temperature at the tip of the PAC will be measured every minute and displayed on the monitor. Two SpotOn™ ZHF temperature monitoring probes (3M, Model 370 Temperature Monitoring System, St. Paul, MN) will be fixed on the skin of the left and right side of the forehead above the eyebrow before induction of anesthesia. These devices also measured core temperature every minute and displayed the values on two display screens. In addition a temperature-sensing indwelling urinary catheter (CovidienTM, Mon-a-ThermTM, Foly Catheter with temperature sensor 400TM) will be placed after induction of anesthesia to allow continuous drainage of urine and continuous measurement of body temperature. Core temperatures measured by PAC, ZHF-thermometer and bladder thermometer will be recorded with an interval of 1 minute. In all patients the core temperature are allowed to drop until going on CPB. There will be no no external warming or infusion warming before CPB. At initiation of CPB measurements will stop because during CPB core temperatures measured with PAC does not produce an accurate estimate of core temperature.

Interventions

DEVICEZero Heat Flux Thermometer

Comparison of the accuracy and precision of a Zero Heat Flux Thermometer (SpotOn) Versus Pulmonary Artery Temperature Measurement

Sponsors

Aalborg University Hospital
CollaboratorOTHER
Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL

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

*

Design outcomes

Primary

MeasureTime frameDescription
ZHF temperature right side versus PAC temperature.PerioperativelyZHF temperature measured on the right side of the forehead versus PAC temperature.
ZHF temperature left side versus PAC temperature.PerioperativelyZHF temperature measured on the left side of the forehead versus PAC temperature.
ZHF temperature right side versus ZHF temperature left sidePerioperativelyZHF temperature measured on the right side of the forehead versus ZHF temperature measured on the left side of the forehead
Bladder temperature versus PAC temperaturePerioperativelyBladder temperature versus PAC temperature

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026