Effect of Preoperative Warming on Intraoperative Hypothermia and Postoperative Functional Recovery Outcomes in Direct Anterior-approached Total Hip Arthroplasty: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Core body temperature
研究概览
简要总结
This prospective, randomized, single-center study compares intraoperative heat loss at the core temperature level in patients scheduled for direct anterior total hip arthroplasty under general anesthesia and who will or will not, according to randomization, receive one hour of pre-warming with a pulsed air thermal blanket prior to anesthesia induction.
详细描述
In patients undergoing surgery, intraoperative hypothermia can occur because of anesthesia-induced inhibition of thermoregulation and heat loss associated with the patient's exposure to an environment maintained at a temperature below normal skin temperature.
Randomized trials show that even mild hypothermia results in serious complications, including surgical wound infection, coagulopathy and increased blood transfusions, and delayed postoperative recovery.
All products used during general anesthesia profoundly alter thermoregulatory control, reducing the activation thresholds of the main defenses against cold, which are the closure of the arteriovenous shunt and the generation of shivering. Impaired thermoregulation, combined with a cold operating room environment and direct-anterior hip surgical approach and exposure, causes hypothermia in almost all unheated patients.
The body core temperature is finely tuned to maintain an average of 37°C by balancing heat gain and loss. The nasopharynx is an excellent alternative to patient core temperature monitoring when esophageal monitoring is excluded for surgical reasons or blocked by an airway protected by an airway device.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Unblinded
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
- •ASA 1-2-3
- •Scheduled for direct anterior-approached total hip replacement surgery under general anesthesia
排除标准
- •pregnant women
- •patients with:
- •peripheral neuropathy or other severe neurological pathology
- •immunosuppression
- •chronic renal insufficiency or severe hepatic insufficiency
- •major congenital or acquired hemostasis disorders
- •craniofacial dysmorphism or anatomical alterations of the upper airways
- •known thermoregulatory disorders
- •patients with a preoperative body temperature > 37.5°C.
结局指标
主要结局
Core body temperature
时间窗: Intraoperative
Variation of core body temperature during surgery, i.e. the difference between the temperature at the time of induction of general anaesthesia and the minimum temperature recorded during the procedure, as well as its evolution over time.
次要结局
- Surgical site infection(30 days after surgery)
- Shivering(First 6 hours after surgery)
- QoR-15(Day-1 and Day-3 after surgery)
- Intraoperative blood loss(Intraoperative)
- LoS(30 days after surgery)
- Postoperative complications(3 days after surgery)
- Patient comfort(First 6 hours after surgery)
研究者
Michele Carella
Head of Clinic, Anesthesiology and Intensive Care Department
University of Liege