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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraoperative hypothermia low risk group | Experimental | 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℃). |
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| Intraoperative hypothermia high risk group | Experimental | 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 ℃. |
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| Model optimization group | Other | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inflatable warming system | Device | 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 ℃. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative hypothermia | Intraoperative hypothermia, defined as a core temperature below 36 °C | Up to 24 hours, from the time of entry into the operating room to the time of exit from the operating room. |
| Measure | Description | Time Frame |
|---|---|---|
| The specificity and sensitivity of the model | Conventional parameters for evaluating model accuracy | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400010 | China |
Data Data available: Yes Data types: Identified participant data How to access data: atpcr7@yeah.net When available: Within 5years after this trial
Supporting Documents Document types: None
Additional Information Who can access the data: Researchers whose proposed use of the data have been approved by Leader Sponsor and Principal Investigator of this trial.
Types of analyses: To be discussed with the steering committee. Mechanisms of data availability: With investigator support after approval signed data access agreement.
Any additional restrictions: None
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| Group of model benefit evaluation | No Intervention | 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. |
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| Prediction of intraoperative hypothermia risk | Diagnostic Test | 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. |
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| The difference between axillary temperatature and core temperature in elderly patients | Other | 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). |
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| Measurement of tympanic membrane temperature | Other | As a intraoperative core temperature reference (measure every 15 minutes) for patients without esophageal temperature or nasopharyngeal temperature monitoring. |
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| Perioperative period |
| Total volume of intraoperative blood loss | Routine intraoperative monitoring indicators | 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. | Up to 60 minutes |
| Postoperative coagulation index | Routine postoperative monitoring indicators | 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 | 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. | Through study completion, an average of 1 year |
| Costs of using active warming | Perioperative period |
| Postoperative hospital costs | The Postoperative hospital cost (￥) from the end of surgery to discharge displayed in the electronic medical record system | 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 | Through study completion, an average of 1 year |
| 30-day postoperative readmission | Routine postoperative monitoring indicators | 30 days after operation |
| 30-day postoperative complications | Routine postoperative monitoring indicators | 30 days after operation |
| 30-day postoperative mortality | Routine postoperative monitoring indicators | 30 days after operation |
| Heart rate | Obtained from multi parameter monitor | Perioperative period |
| Blood pressure | Obtained from multi parameter monitor | Perioperative period |
| Blood oxygen saturation | Obtained from multi parameter monitor | Perioperative period |