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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,323
Inflatable warming system, including a forced air warming system (IOB, WU505) and forced air warming blanket (IOB-001, IOB-006, IOB-011), 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 ℃.
According to the Intelligent Care For The Elderly (ICE, an optimized model based on the existing prediction model of our research group after dynamic incremental training), patients are divided into intraoperative hypothermia lowrisk group and intraoperative hypothermia high risk group.
Previous studies have shown that the difference and standard deviation between esophageal temperature and axillary temperature are core 0.05 ℃ and 0.26 ℃, respectively. In light of 10% dropout rate, a integer sample size of 400 achieves 95% power to detect a mean of paired differences of 0.05 with an estimated standard deviation of paired differences of 0.26 and with a significance level (alpha) of 0.05 using a two-sided paired t-test. So 400 patients in the Model optimization group need to undergo core temperature (esophageal temperature or nasopharyngeal temperature).
As a intraoperative core temperature reference (measure every 15 minutes) for patients without esophageal temperature or nasopharyngeal temperature monitoring.
First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Intraoperative hypothermia
Intraoperative hypothermia, defined as a core temperature below 36 °C
Time frame: Up to 24 hours, from the time of entry into the operating room to the time of exit from the operating room.
The specificity and sensitivity of the model
Conventional parameters for evaluating model accuracy
Time frame: 1 year
Physical sensation
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)
Time frame: Perioperative period
Total volume of intraoperative blood loss
Routine intraoperative monitoring indicators
Time frame: Intraoperative
Postoperative shivering
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.
Time frame: Up to 60 minutes
Postoperative coagulation index
Routine postoperative monitoring indicators
Time frame: Within 24 hours after operation
Postoperative hospital stay
The number of days from the end of surgery to discharge displayed in the electronic medical record system for patients
Time frame: Through study completion, an average of 1 year
Total hospital stay
The number of days from admission to discharge displayed in the electronic medical record system for patients.
Time frame: Through study completion, an average of 1 year
Costs of using active warming
Time frame: Perioperative period
Postoperative hospital costs
The Postoperative hospital cost (￥) from the end of surgery to discharge displayed in the electronic medical record system
Time frame: Through study completion, an average of 1 year
Total hospital costs
The Total hospital cost (￥) from admission to discharge displayed in the electronic medical record system
Time frame: Through study completion, an average of 1 year
30-day postoperative readmission
Routine postoperative monitoring indicators
Time frame: 30 days after operation
30-day postoperative complications
Routine postoperative monitoring indicators
Time frame: 30 days after operation
30-day postoperative mortality
Routine postoperative monitoring indicators
Time frame: 30 days after operation
Heart rate
Obtained from multi parameter monitor
Time frame: Perioperative period
Blood pressure
Obtained from multi parameter monitor
Time frame: Perioperative period
Blood oxygen saturation
Obtained from multi parameter monitor
Time frame: Perioperative period
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