Research on Intraoperative Hypothermia Risk Prediction Model and Temperature Management Strategy for Elderly Patients During Surgery Based on Dynamic Incremental Training

NARecruitingINTERVENTIONAL
Enrollment

2,424

Participants

Timeline

Start Date

March 11, 2025

Primary Completion Date

November 30, 2025

Study Completion Date

December 31, 2025

Conditions
Intraoperative Hypothermia
Interventions
DEVICE

Inflatable warming system

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 ℃.

DIAGNOSTIC_TEST

Prediction of intraoperative hypothermia risk

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.

OTHER

The difference between axillary temperatature and core temperature in elderly patients

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).

OTHER

Measurement of tympanic membrane temperature

As a intraoperative core temperature reference (measure every 15 minutes) for patients without esophageal temperature or nasopharyngeal temperature monitoring.

Trial Locations (1)

400010

RECRUITING

First Affiliated Hospital of Chongqing Medical University, Chongqing

All Listed Sponsors
lead

First Affiliated Hospital of Chongqing Medical University

OTHER