Establishment of Systemic Prevention and Management for Perioperative Hypothermia and Its Effect on Patients Outcome-a Prospective Multiple Centers Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 800
- 主要终点
- Incidence of intraoperative hypothermia
研究概览
简要总结
This is a randomized, single-blinded, multi-center study clinical trial to determine both clinical and health outcomes of stratified warm strategy to prevent intraoperative hypothermia. Participants enrolled into this trial will be from elective major surgery population in PUMC Hospital, Beijing Hospital and Xuanwu Hospital. investigators plan to enroll approximately 800 participants. Hypothermia risk will be evaluated through PREDICTOR model in all participants. According to hypothermia risk level, these participants will be stratefied into high, moderate and low risk group. Participants in each group will be randomly categorize into warm group and control group. Active warm and fluid warm strategy, prewarm and fluid warm strategy and only prewarm strategy are used for high risk, moderate risk and low risk patients seperately. For controll group traditional passive warm was used.
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
- Single (Participant)
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
- •Age≥18 Core temperature preoperation ≥36.0 ℃ and ≤37.5℃ ASA I-III Informed consent
排除标准
- •emergency operation
- •uncontrolled diebete mellitus with insulin treatment （preoperative blood glucose>250mg/dL）
- •hyperthyroidism and hypothyroidism
- •Raynaud's disease
- •patients with hematopathy and immune disease
- •anticoagulant and non-steroid anti-inflammatory drug intake with 14 days before operation
- •infectious fever within 4 weeks before operation
- •laboratory abnomality as follow
- •Hemoglobin≤10.0g/L
- •Platelet≤100,000/ml
- •White blood cell<3000/dl or>14,000/dl
- •Fibrinogen<200mg/dL
- •Thrombin time>40 second
- •International normalized ratio<70%
研究组 & 干预措施
control group
Cotton Blanket Warming (CBW) starts 30 min preoperatively and then continues throughout the entire operation.
干预措施: passive warming (Other)
warm group
Warm according to different hypothermia risk for low risk ---Forced-air warming(FAW) starts at least 30 min preoperatively and then Cotton Blanket Warming (CBW) continues throughout the entire operation.
moderate risk---Forced-air warming(FAW) starts at least 30 min preoperatively and then Cotton Blanket Warming (CBW) and fluid warming continues throughout the entire operation.
high risk ----Forced-air warming(FAW) starts at least 30 min preoperatively, FAW and fluid warming continues throughout the entire operation.
干预措施: high risk warm (Combination Product)
warm group
Warm according to different hypothermia risk for low risk ---Forced-air warming(FAW) starts at least 30 min preoperatively and then Cotton Blanket Warming (CBW) continues throughout the entire operation.
moderate risk---Forced-air warming(FAW) starts at least 30 min preoperatively and then Cotton Blanket Warming (CBW) and fluid warming continues throughout the entire operation.
high risk ----Forced-air warming(FAW) starts at least 30 min preoperatively, FAW and fluid warming continues throughout the entire operation.
干预措施: moderate risk warm (Combination Product)
warm group
Warm according to different hypothermia risk for low risk ---Forced-air warming(FAW) starts at least 30 min preoperatively and then Cotton Blanket Warming (CBW) continues throughout the entire operation.
moderate risk---Forced-air warming(FAW) starts at least 30 min preoperatively and then Cotton Blanket Warming (CBW) and fluid warming continues throughout the entire operation.
high risk ----Forced-air warming(FAW) starts at least 30 min preoperatively, FAW and fluid warming continues throughout the entire operation.
干预措施: low risk warm (Combination Product)
结局指标
主要结局
Incidence of intraoperative hypothermia
时间窗: During operation
Core temperature\<36℃
次要结局
- Length of stay in PACU(Postoperative during in postanaesthesia care unit， up to 24 hours after surgery)
- digit span test.(One day preoperation and 1 , 7，30 days postoperation)
- Lenght of Stay in hospital(impatient period， up to 6 month after surgery)
- Incidence of Adverse cardiovascular events(WIthin 6 month post operation)
- Mini-Mental State Examination (MMSE),(One day preoperation and 1 , 7，30 days postoperation)
- Incidence of shiver(during in postanaesthesia care unit， up to 24 hours after surgery)
- Auditory Verbal Learning Test,(One day preoperation and 1 , 7，30 days postoperation)
- The amount of Intraoperative blood loss/blood transfusion(During operation)
- The incidence of Surgical site infection(WIthin 30 days postoperative)
- Lenght of Stay in ICU(impatient period， up to 6 month after surgery)
- digit symbol substitution test(One day preoperation and 1 , 7，30 days postoperation)
- Color Word Stroop Test(One day preoperation and 1 , 7，30 days postoperation)
- postoperative cognitive dysfunction incidence(One day preoperation and 1 , 7，30 days postoperation)
研究者
Jie YI
Vice director
Peking Union Medical College Hospital