NCT05430997已完成不适用
Hypothermia Risk Prediction Combined With Active Insulation Management in the Burden of Disease Study in Geriatric Surgery: A Multicenter, Randomized, Controlled Study Based on 24 Hospitals in Southwest China
First Affiliated Hospital of Chongqing Medical University1 个研究点 分布在 1 个国家目标入组 1,360 人开始时间: 2022年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,360
- 试验地点
- 1
- 主要终点
- Incidence of intraoperative hypothermia
研究概览
简要总结
To evaluate the effectiveness and safety of hypothermia risk prediction combined with active warming management to reduce intraoperative hypothermia in elderly patients undergoing elective general anesthesia, improve the quality of anesthesia management, and enhance patients' awareness of the work of anesthesiologists.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years, male or female.
- •Elective general anesthesia for surgery.
- •Operative time ≥ 30 min.
- •Preoperative body temperature within the normal range.
- •Normal preoperative bleeding and clotting time.
排除标准
- •Mental illness.
- •High or low basal hypothermia with high or low metabolic disease (patients with central hyperthermia include those with cerebrovascular vascular disease, traumatic brain injury and brain surgery, epilepsy, central hyperthermia due to acute hydrocephalus; thermoregulatory abnormalities including malignant hyperthermia (MHS), neuroleptic malignant syndrome and those with definite evidence of diagnosed hypo- or hyperthyroidism and current abnormal thyroid function).
- •Impaired skin insulation barriers such as large skin burns.
- •Infectious fever.
- •Other causes of body temperature above 38.5 °C three days before surgery.
- •Other persons deemed unsuitable by the investigator to participate in the clinical trial.
- •Refusal to sign the informed consent form.
结局指标
主要结局
Incidence of intraoperative hypothermia
时间窗: Up to 24 hours, from the time of entry into the operating room to the time of exit from the operating room.
Intraoperative hypothermia, defined as a core temperature below 36 °C
次要结局
- Postoperative blood count(up to 24 hours after surgery)
- 30-day postoperative readmission(30 days after surgery)
- Postoperative coagulation index(up to 24 hours after surgery)
- Intraoperative fluid transfusion(15 minutes before the end of the surgery)
- Shivering severity(60 minutes)
- Postprocedural Shivering(up to 60 minutes)
- Intraoperative bleeding volume(up to 24 hours after surgery)
- 6-month postoperative complications (surgical complications, pulmonary infections, blood clots)(6 months after surgery)
- 30-day postoperative mortality(30 days after surgery)
- Intraoperative blood transfusion volume(15 minutes before the end of the surgery)
- 30-day postoperative complications (surgical complications, pulmonary infections, blood clots)(30 days after surgery)
- intraoperative flushing fluid volume(15 minutes before the end of the surgery)
研究者
Min Su
Professor.Min
First Affiliated Hospital of Chongqing Medical University
研究点 (1)
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