Impact of a Global Warming Strategy, From the Patient Arrival in the Operating Room to His Discharge From the Recovering Room, Versus a Recommended Management of Intraoperative Warming on the Prevalence of Hypothermia in the Recovering Room
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, the prevalence of hypothermia at the exit of Interventional for patients who underwent laparoscopic visceral surgery.
研究概览
简要总结
50% of patients are hypothermic when they arrive in the recovery room. This hypothermia is potentially at risk for the patient (increases bleeding, risk of infection, risk of cardiac involvement, morbid mortality) and 33,2% steel hypothermic when they discharge from the recovering room. The anesthesia team must prevent these risks through prevention and treatment measures. Currently the majority of patient warming is done only in the operating room, we want to measure the impact of the extension of this warming before and after the surgery on the patient's temperature and on side effects related to hypothermia.
详细描述
Hypothermia is defined as a core temperature below 36°C. It is classified by severity stage. A temperature below 36°C is mild hypothermia, below 35°C moderate hypothermia and below 34°C severe hypothermia.
The impact of hypothermia on the body is related to decreased metabolic and immune activities. The vasoconstriction induced by hypothermia implies a decrease in vascularization of the organs that can cause tissue damage.
These effects explain the role of hypothermia in the pathophysiology of certain perioperative and postoperative complications in the longer term.
Intraoperative hypothermia is responsible for the increase of:
- 4 times the risk of Surgical Site Infection,
- twice the risk of cardiovascular morbidity, associated with increased mortality,
- 33% of transfusion need,
- 1.5 times the need for continued mechanical ventilation,
- 3 times the duration of recovering room,
- twice the hospital stay. This is why hypothermia is responsible for excess perioperative mortality.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing laparoscopic visceral surgery under general anesthesia with transition to recovering room
排除标准
- •Patient undergoing urgent surgery.
- •Presence of pre-existing infection (temperature higher than 38°C when receiving the patient in the hospital ward.
- •Patient with predetermined length of stay in recovering room.
研究组 & 干预措施
RéGlo arm
Innovative support with global warming strategy.
干预措施: global warming (Other)
Control arm
Support according to recommendations
干预措施: per operative warming (Other)
结局指标
主要结局
Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, the prevalence of hypothermia at the exit of Interventional for patients who underwent laparoscopic visceral surgery.
时间窗: 1 day
Proportion of patients with hypothermia after discharge of recovering room. Hypothermia is defined as a body temperature \< 36°C.
次要结局
- Compare between the experimental group of global warming (RéGlo) and the control group of per- operative warming, the average thermal comfort of preoperative patients, on arrival in the recovering room(1 day)
- Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, the proportion of patients in intraoperative hypothermia(1 day)
- Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, the average thermal comfort of preoperative patients, on arrival in the pre- anesthesia room(1 day)
- Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, The average time spent below 36°C (mild hypothermia)(1 day)
- Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, The average time spent below 34°C (severe hypothermia)(1 day)
- The average thermal variation in per operative(1 day)
- the average thermal variation in post operative(1 day)
- Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, The average time spent below 35°C (moderate hypothermia)(1 day)
- Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, Post-intervention complications in recovering room, the average number of Nausea or Vomiting Postoperative(1 day)
- The general average of the thermal variation(1 day)
- The average length of stay in recovering room(1 day)
- Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, the average total mechanical ventilation time(1 day)
- Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, The lowest average temperature reached in °C over the entire management(1 day)
- Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, The proportion of hypothermic patients arriving in recovering room(1 day)
- Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, The average duration of oxygen therapy(1 day)
- Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, Post-intervention complications in recovering room, the average number of chills(1 day)
- The average amount of blood loss per operation(1 day)
- The average of immediate post-operative blood loss(1 day)
- Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, Post-intervention complications in recovering room, the average number of stirring phase presence(1 day)
- The average of thermal variation in pre operative(1 day)