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Completed

NCT Number: NCT05737147

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

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.

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Key information

Conditions

Temperature Monitoring Cardiac Surgical Procedures

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet, Copenhagen University Denmark

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zero Heat Flux Thermometer

Device

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

Other names: Pulmonary Artery Temperature

Primary outcomes

  1. ZHF temperature right side versus PAC temperature.

    Time frame: Perioperatively

    ZHF temperature measured on the right side of the forehead versus PAC temperature.

  2. ZHF temperature left side versus PAC temperature.

    Time frame: Perioperatively

    ZHF temperature measured on the left side of the forehead versus PAC temperature.

  3. ZHF temperature right side versus ZHF temperature left side

    Time frame: Perioperatively

    ZHF temperature measured on the right side of the forehead versus ZHF temperature measured on the left side of the forehead

  4. Bladder temperature versus PAC temperature

    Time frame: Perioperatively

    Bladder temperature versus PAC temperature

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Aalborg University Hospital

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Feb 21, 2023
Registry last updated
Mar 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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