Research on Intraoperative Hypothermia Risk Prediction and Temperature Management Strategies in Elderly Patients: Construction of Intraoperative Hypothermia Prediction Model Based on Dynamic Incremental Training and Evaluation of Clinical Application Effectiveness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,323
- 试验地点
- 2
- 主要终点
- Intraoperative hypothermia
研究概览
简要总结
With the support of partial dual temperature monitoring (comparing the specific difference between standardized axillary temperature monitoring and esophageal temperature), this trial is divided into the following three parts:
- Multi center observational study: Establish and validate a dynamic incremental training intraoperative hypothermia prediction model - Intelligent Care for the Elderly (ICE) - Intraoperative hypothermia warning system, and provide ICE Offline for use by healthcare professionals and ICE Online for further model updates when needed for clinical or research purposes.
- Multi center non randomized controlled clinical trial: Conduct a multi center stratified temperature management clinical trial based on ICE Offline after dynamic incremental training to verify the clinical and economic benefits of the model and active warming.
- Pre and post comparative study: Collect data before ICE application and compare it with data after ICE promotion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Elderly patients (aged 60 and above) undergoing non cardiac elective surgery under general anesthesia;
- •30 minutes ≤ Estimated surgical duration ≤ 240 minutes ;
- •Normal preoperative bleeding and clotting time
- •American society of Aneshesiologists physical status classification system:Ⅰ～Ⅳ
排除标准
- •Mental illness
- •Cirrhosis
- •Existence or potential central hyperthermia
- •Metabolic thermoregulatory abnormalities
- •History of malignant hyperthermia or family history
- •Extensive skin burns or injuries
- •Seriously infect
- •Long term use of nonsteroidal anti-inflammatory drugs
- •Expected difficult airway
- •Researchers believe that individuals who are not suitable to participate in clinical trial
- •Refusal to sign informed consent form
- •Withdraw informed consent form
- •Severe bleeding or shock during perioperative period.
研究组 & 干预措施
Intraoperative hypothermia low risk group
Patients included this group are determined by prediction model. Operating room environment temperature was set at not less than 21°C, with a relative humidity of 50% to 60%. Patients are covered from neck to feet with a cotton blanket and the area to be disinfected and operated on is uncovered after induction of anesthesia. All patients will be administered intravenous fluid warmers and irrigation fluid prewarming (37℃~43℃).
干预措施: Prediction of intraoperative hypothermia risk (Diagnostic Test)
Intraoperative hypothermia low risk group
Patients included this group are determined by prediction model. Operating room environment temperature was set at not less than 21°C, with a relative humidity of 50% to 60%. Patients are covered from neck to feet with a cotton blanket and the area to be disinfected and operated on is uncovered after induction of anesthesia. All patients will be administered intravenous fluid warmers and irrigation fluid prewarming (37℃~43℃).
干预措施: Measurement of tympanic membrane temperature (Other)
Intraoperative hypothermia high risk group
Patients included this group are determined by prediction model. In addition to the measures taken in intraoperative hypothermia low risk group, an inflatable warming system, including a forced air warming system and forced air warming blanket, is employed for prewarming before anesthesia initiation and for maintaining body temperature throughout the operation. During the surgery, the insulation blanket will be applied to non surgical areas, and the host temperature will be adjusted to 38 ℃ for warming. If the temperature of the patient is lower than 36 ℃, the temperature of the system can be adjusted to 43 ℃; if the temperature of the patient is higher than 37 ℃, the temperature of the system can be adjusted to 32 ℃. After the patient's temperature is normal, it can be adjusted back to 38 ℃.
干预措施: Inflatable warming system (Device)
Intraoperative hypothermia high risk group
Patients included this group are determined by prediction model. In addition to the measures taken in intraoperative hypothermia low risk group, an inflatable warming system, including a forced air warming system and forced air warming blanket, is employed for prewarming before anesthesia initiation and for maintaining body temperature throughout the operation. During the surgery, the insulation blanket will be applied to non surgical areas, and the host temperature will be adjusted to 38 ℃ for warming. If the temperature of the patient is lower than 36 ℃, the temperature of the system can be adjusted to 43 ℃; if the temperature of the patient is higher than 37 ℃, the temperature of the system can be adjusted to 32 ℃. After the patient's temperature is normal, it can be adjusted back to 38 ℃.
干预措施: Prediction of intraoperative hypothermia risk (Diagnostic Test)
Intraoperative hypothermia high risk group
Patients included this group are determined by prediction model. In addition to the measures taken in intraoperative hypothermia low risk group, an inflatable warming system, including a forced air warming system and forced air warming blanket, is employed for prewarming before anesthesia initiation and for maintaining body temperature throughout the operation. During the surgery, the insulation blanket will be applied to non surgical areas, and the host temperature will be adjusted to 38 ℃ for warming. If the temperature of the patient is lower than 36 ℃, the temperature of the system can be adjusted to 43 ℃; if the temperature of the patient is higher than 37 ℃, the temperature of the system can be adjusted to 32 ℃. After the patient's temperature is normal, it can be adjusted back to 38 ℃.
干预措施: Measurement of tympanic membrane temperature (Other)
Model optimization group
Only observe the patient's baseline, intraoperative hypothermia, postoperative complications, and other indicators, and collect data through the electronic Data Capture System to optimize existing intraoperative hypothermia prediction model. The estimated sample size is 600 cases by the incremental learning curve calculating.
干预措施: The difference between axillary temperatature and core temperature in elderly patients (Other)
Model optimization group
Only observe the patient's baseline, intraoperative hypothermia, postoperative complications, and other indicators, and collect data through the electronic Data Capture System to optimize existing intraoperative hypothermia prediction model. The estimated sample size is 600 cases by the incremental learning curve calculating.
干预措施: Measurement of tympanic membrane temperature (Other)
Group of model benefit evaluation
Data of this group is medical records before the application of the intraoperative hypothermia prediction model, which will be collected from the electronic medical record system.
结局指标
主要结局
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
- The specificity and sensitivity of the model(1 year)
- Physical sensation(Perioperative period)
- Total volume of intraoperative blood loss(Intraoperative)
- Postoperative shivering(Up to 60 minutes)
- Postoperative coagulation index(Within 24 hours after operation)
- Postoperative hospital stay(Through study completion, an average of 1 year)
- Total hospital stay(Through study completion, an average of 1 year)
- Costs of using active warming(Perioperative period)
- Postoperative hospital costs(Through study completion, an average of 1 year)
- Total hospital costs(Through study completion, an average of 1 year)
- 30-day postoperative readmission(30 days after operation)
- 30-day postoperative complications(30 days after operation)
- 30-day postoperative mortality(30 days after operation)
- Heart rate(Perioperative period)
- Blood pressure(Perioperative period)
- Blood oxygen saturation(Perioperative period)
研究者
Min Su
Director
First Affiliated Hospital of Chongqing Medical University