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临床试验/NCT05737147
NCT05737147已完成不适用

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.

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
ZHF temperature right side versus ZHF temperature left side

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

ZHF temperature right side versus ZHF temperature left side

时间窗: Perioperatively

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

ZHF temperature right side versus PAC temperature.

时间窗: Perioperatively

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

ZHF temperature left side versus PAC temperature.

时间窗: Perioperatively

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

Bladder temperature versus PAC temperature

时间窗: Perioperatively

Bladder temperature versus PAC temperature

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carsten Michel Pedersen

Clinical nurse specialist

Rigshospitalet, Denmark

研究点 (1)

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