Effectiveness of Spot-on ™ to Prevent Inadvertent Perioperative Hypothermia and Their Consecuences
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- change in the Body Core Temperature
研究概览
简要总结
Using the spot-on device for monitoring core body temperature during colon laparoscopic surgery and prevent non-therapeutic hypothermia.
详细描述
Take active measures to prevent non-therapeutic hypothermia during the laparoscopic colon surgery. We improve these measures using heat conductive air warm blankets placed under and o over the patient.
Perform monitoring core body temperature every 15 minutes by spot-on device compared with standard nasopharyngeal probe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients that need a colorrectal laparoscopic surgery
排除标准
- •Use of antagonist of Calcium
- •Alergy to medications
- •History of Malignant Hipertemia
- •Laparosocopy surgery ≥ 120 min
- •Temperature previous surgery over 38ºC
- •Taking chronic steroids
研究组 & 干预措施
Spot-on group
Use active measures against intraoperative hypothermia
干预措施: Spot-On (Device)
control
standard measures against intraoperative hipothermia
结局指标
主要结局
change in the Body Core Temperature
时间窗: measure every 15 minutes since the patient arrive to operating room until is derivated to recovery room, an average of 3 hours
measure the body core temperature by Spoton device when the patient arrive to operating room
次要结局
- incidence of blood transfusion(In the first two weeks after being operated.)
- surgical wound infection(while the patient stay in the hospital, an average of two weeks)
研究者
Unai Ortega Mera
Doctor
Osakidetza