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: Recruiting
Location: See location...
Intervention Type: Device, Other, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
China
First Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
Contact Information
Primary
Su Min
201371@cqmu.edu.cn
13508302749
Time Frame
Start Date: 2025-03-11
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 1200
Treatments
Experimental: Intraoperative hypothermia low risk group
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℃).The estimated sample size calculated using PASS is 120 cases.
Experimental: Intraoperative hypothermia high risk group
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 (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 ℃.~The estimated sample size calculated using PASS is 120 cases.
Other: Model optimization group
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.
No_intervention: Group of model benefit evaluation
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. Estimated sample size is 240 cases.
Related Therapeutic Areas
Sponsors
Leads: First Affiliated Hospital of Chongqing Medical University

This content was sourced from clinicaltrials.gov