The Use of Thermal Suits as Preventing Hypothermia During Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Temperature
研究概览
简要总结
Unintentional hypothermia of a patient is a common adverse effect during surgical procedures. The aim of this prospective, randomised, controlled study is to determine whether the use of thermal suit could prevent surgical patient from experiencing thermal loss than conventional measures.
Hypothesis: The investigators assume that a difference of 0.5°C in body temperature between the groups is clinically relevant.
详细描述
The aim of this study was to compare a thermal suit (T-Balance) and conventional warming methods to maintain a constant body temperature in patients undergoing robotic laparoscopic radical prostatectomy under general anesthesia.
A sample size calculation was made using a power analysis. Patients were randomly allocated into two groups.
Patients in the intervention group were put on the T-Balance 1 hour before anesthesia induction. Patients in the control group got conventional cotton clothes. Intra-operatively same warming methods were used in both groups. The measuring points of the temperature were esophagus (core temperature), left axilla, dorsal surface of the left middle finger and back of the left foot.
Anesthesia was induced via target-controlled infusion. All temperature data of the patients were collected and recorded electrically and continuously.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •radical prostatectomy, American Society of Anaesthesiologists class I-III, age 18-90
排除标准
- •mental status with inability to give informed consent, neuromuscular disorders, Raynaud's disease, unstable angina pectoris
研究组 & 干预措施
Thermal suit
Randomly selected half of the patients will use thermal suit prior to anesthesia, during the surgery and post anesthesia care unit.
干预措施: Thermal suit (Device)
Conventional clothing
Randomly selected half of the patients will use conventional clothing prior to anesthesia, during the surgery and post anesthesia care unit.
干预措施: Conventional clothing (Other)
结局指标
主要结局
Temperature
时间窗: from one hour before surgery up to the ward after surgery, estimated 10 hours
次要结局
未报告次要终点