Comparison of the Accuracy & Precision of a Zero Heat Flux Thermometer

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05737147
Study type	Observational
Source	Rigshospitalet, Denmark
Contact
Status	Completed
Phase
Start date	September 1, 2018
Completion date	July 1, 2022

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT04293744` - Acute Kidney Injury After Cardiac Surgery	N/A
Completed	`NCT01184521` - Masimo CO-Oximeter Study	Phase 0
Completed	`NCT05537168` - Bayesian Networks in Pediatric Cardiac Surgery
Completed	`NCT04269109` - Opioid Sparing Pain Management Strategy
Completed	`NCT04911413` - Comparison of Three Tranexamic Acid Dose Regimens in Patients Undergoing Cardiac Valve Surgery	Phase 4
Recruiting	`NCT02580292` - Diagnostic Accuracy of Doppler Resistive Indices for Early Diagnosis of Acute Kidney Injury .
Completed	`NCT02457572` - Pulse Pressure Variation Measured During Valsalva Maneuver to Predict Fluid Responsiveness Under Open-chest Condition	N/A
Completed	`NCT00997217` - The Effect of Remote Ischemic Preconditioning in the Cardiac Surgery	Phase 1
Recruiting	`NCT05454735` - Glycemic Variability and Autonomic Nervous System in Cardiac Surgery Patients
Completed	`NCT01169441` - Lead Extract Study	N/A
Completed	`NCT00336908` - Inflammatory Responses to Lipid Emulsions in Children Before and After Open Heart Surgery	Phase 2/Phase 3
Terminated	`NCT05308589` - CPPF After General Cardiac Surgery	N/A
Recruiting	`NCT03163238` - Dexmedetomidine and the Inflammatory Response in Pediatric Cardiac Surgery	Phase 2
Completed	`NCT02329158` - Disinvestment in Hydroxyl-ethyl Starches (HES) for Cardiac Surgery
Completed	`NCT01029314` - Pilot Study of the Genius(TM)2 Tympanic Thermometer in Cardiac Patients Requiring Cardiopulmonary Bypass	N/A
Completed	`NCT00459082` - A Pharmacokinetic Study of Dexmedetomine in Infants	Phase 1
Completed	`NCT00122018` - An Investigation of N-acetylcysteine and Fenoldopam as Renal Protection Agents for Cardiac Surgery	Phase 2
Terminated	`NCT03709693` - Clinical Outcomes in Patients Treated With SternaLock Blu
Completed	`NCT03976947` - Impact of Lung Recruitment Maneuvers on Driving Pressure in Cardiac Surgery
Completed	`NCT02398019` - Clinical Trial to Evaluate the Use of an Adsorption Membrane (oXiris®) During Cardiopulmonary Bypass Surgery	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms