Effects of Preoperative Warming of Patients on Postoperative Hypothermia and Shivering.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 4
- 主要终点
- Incidence of hypothermic (body temperature < 36°C) patients at postoperative arrival at postoperative care unit (PACU)
研究概览
简要总结
The investigators want to evaluate the effect of prewarming on the rate of postoperative hypothermia and shivering and to compare sublingual versus tympanic temperature assessment during the perioperative period in patients.
Patients will be randomly assigned to 4 groups with different duration of prewarming. Body temperature will be recorded regularly by sublingual and tympanic (by thermocouple) measurement. Incidence of hypothermia (temp. < 36°C) and shivering will be assessed postoperatively.
详细描述
Inadvertent perioperative hypothermia causes many serious complications. Therefore, prevention from, detection and therapy of hypothermia is essential. The appropriate methods of temperature assessment are still under debate as well as the effect and necessary duration of active prewarming of patients to avoid postoperative hypothermia and shivering.
The aim of our study is to evaluate the effect of prewarming on the rate of postoperative hypothermia and shivering and to compare sublingual versus tympanic temperature assessment during the perioperative period in patients undergoing elective minor surgery.
The investigators plan to include patients scheduled for routine minor surgery of approximately 1h duration. Patients will be randomly assigned to 4 groups with different duration of active prewarming. Body temperature will be recorded regularly by sublingual and tympanic (by thermocouple) measurement. Incidence of hypothermia (temp. < 36°C) and shivering will be assessed postoperatively.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients scheduled for minor surgery (planned duration approximately <1h).
- •Age 18-75yrs,
- •ASA I-II physical status
排除标准
- •Emergency surgery,
- •pregnant patients,
- •patients not able to give informed consent,
- •duration of surgery >2h,
- •necessary postoperative mechanical ventilation
结局指标
主要结局
Incidence of hypothermic (body temperature < 36°C) patients at postoperative arrival at postoperative care unit (PACU)
时间窗: postoperative arrival at PACU (once)
After surgery patients will be admitted to PACU. Body temperature will be evaluted here to study the number of hypothermic patients depended from duration of preoperative warming.Time frame for assessment of data: 5 min after postoperative arrival at PACU (one single measurement, duration: 30 sec).Afterwards patients will be observed for about 2h.
次要结局
- Performance of sublingual vs. tympanic temperature assessment preoperatively in awake patients.(preoperatively (once) at arrival at PACU)
- Performance of sublingual vs. tympanic temperature assessment postoperatively in awake patients.(at postoperative arrival at PACU, once)
- Performance of sublingual vs. tympanic temperature assessment intraoperatively in anaesthetised patients.(intraoperatively (30 min after start of surgery), once)
研究者
PD Dr. Jan Hoecker
PD Dr. Jan Höcker
University Hospital Schleswig-Holstein