NCT06676735

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,323 (actual)
• Sponsor: First Affiliated Hospital of Chongqing Medical University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Intraoperative Hypothermia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-11
• Primary completion: 2025-12-15
• Completion: 2026-01-14
• First posted: 2024-11-06
• Last updated: 2026-01-16

Locations

1 site across 1 country: China