Research on Intraoperative Hypothermia Risk Prediction Model and Temperature Management Strategy for Elderly Patients During Surgery Based on Dynamic Incremental Training
- Conditions
- Intraoperative Hypothermia
- Registration Number
- NCT06676735
- Lead Sponsor
- First Affiliated Hospital of Chongqing Medical University
- Brief Summary
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:
1. 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.
2. 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.
3. Pre and post comparative study: Collect data before ICE application and compare it with data after ICE promotion.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 2424
- Elderly patients (aged 60 and above) undergoing non cardiac elective surgery under general anesthesia;
- Surgical duration ≥ 30 minutes;
- Normal preoperative bleeding and clotting time
- American society of Aneshesiologists physical status classification system:Ⅰ～Ⅳ
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Intraoperative hypothermia 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
- Secondary Outcome Measures
Name Time Method 30-day postoperative mortality 30 days after operation Routine postoperative monitoring indicators
Heart rate Perioperative period Obtained from multi parameter monitor
Blood pressure Perioperative period Obtained from multi parameter monitor
Blood oxygen saturation Perioperative period Obtained from multi parameter monitor
The specificity and sensitivity of the model 1 year Conventional parameters for evaluating model accuracy
Physical sensation Perioperative period The ASHRAE thermal sensation scale, which was developed for use in quantifying people's thermal sensation, is defined as follows:+3 (hot), +2 (warm), +1 (slightly warm), 0 (neutral), -1 (slightly cool), -2(cool), and -3 (cold)
Total volume of intraoperative blood loss Intraoperative Routine intraoperative monitoring indicators
Postoperative shivering Up to 60 minutes A compensatory response of the body to hypothermic stimuli that cause rapid rhythmic. Once the operation is completed, the patient will be extubated and the presence or absence of shivering will be recorded up to 60 minutes after the extubation with the Badjatia 2008 scale consisting of a gradual evaluation of 0 to 3 points. With scores greater or equal to 1, shivering is considered established.
Postoperative coagulation index Within 24 hours after operation Routine postoperative monitoring indicators
Postoperative hospital stay Through study completion, an average of 1 year The number of days from the end of surgery to discharge displayed in the electronic medical record system for patients
Total hospital stay Through study completion, an average of 1 year The number of days from admission to discharge displayed in the electronic medical record system for patients.
Costs of using active warming Perioperative period Postoperative hospital costs Through study completion, an average of 1 year The Postoperative hospital cost (￥) from the end of surgery to discharge displayed in the electronic medical record system
Total hospital costs Through study completion, an average of 1 year The Total hospital cost (￥) from admission to discharge displayed in the electronic medical record system
30-day postoperative readmission 30 days after operation Routine postoperative monitoring indicators
30-day postoperative complications 30 days after operation Routine postoperative monitoring indicators