Central Temperature Monitoring by Zero-heath-flux a Non-invasive Technic Compared to Two Invasive Technic During Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- temperature monitoring with Zero-Heath-Flux (SpotOn)
研究概览
简要总结
Core temperature monitoring is mandatory during major surgery. The accurate techniques currently used are invasive, such as artery catheter and oesophagal probe. A new non-invasive cutaneous device, 3M SpotOn, using Zero Heath-Flux method, continuously measure core temperature. This prospective study compare the accuracy of Zero-Heath-Flux to oesophagal temperature (30 patients) and to artery catheter (20 patients) in adult patients during surgery.
详细描述
Every patients undergoing heavy surgery had their central temperature monitoring, through an arterial catheter if the surgery required it (30 patients in this arm), otherwise the investigators used an oesophagus tube (20 patients). We also monitored every 50 patients with a non-invasive method 3M spot on (Zero-heath-flux technic) in order to measure its fiability and validity during the surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled to undergo general anaesthesia for gut surgery lasting more than 2 hours
- •Patients with core temperature monitored with oesophagal probe only (30 patients) or with oesophagal probe and PICCO device (20 patients)
- •Patients without opposition to this study after informations given
排除标准
- •Patients with frontal cutaneous decay wich avoid using 3M Spot-on
- •Patients whom oesophagal probe was prohibited (oesophagal varices, oesophagal surgery)
- •Pregnant women or breast-feeding, women who may become pregnant unless adequate contraceptive measures
研究组 & 干预措施
monitoring by arterial catheter and Spot-on
干预措施: Monitoring by arterial catheter and Spot-on (Device)
monitoring by oesophagus tube and Spot-on
干预措施: Monitoring by oesophagal probe and Spot-on (Device)
结局指标
主要结局
temperature monitoring with Zero-Heath-Flux (SpotOn)
时间窗: 1 day
temperature monitoring with arterial catheter (PICCO)
时间窗: 1 day
temperature monitoring with oesophagal probe (Coviden)
时间窗: 1 day
次要结局
未报告次要终点