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

Chongqing Medical University

Status: Completed

Conditions: Intraoperative Hypothermia

Treatments: Other: The difference between axillary temperatature and core temperature in elderly patients; Diagnostic Test: Prediction of intraoperative hypothermia risk; Other: Measurement of tympanic membrane temperature; Device: Inflatable warming system

Study type: Interventional

Funder types: Other

Identifiers

NCT06676735

ZZ2024-173-01

Details and patient eligibility

About

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.

Enrollment: 1,323 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Elderly patients (aged 60 and above) undergoing non cardiac elective surgery under general anesthesia;
• 30 minutes ≤ Estimated surgical duration ≤ 240 minutes ;
• Normal preoperative bleeding and clotting time
• American society of Aneshesiologists physical status classification system:Ⅰ～Ⅳ

Exclusion criteria

• Mental illness
• Cirrhosis
• Existence or potential central hyperthermia
• Metabolic thermoregulatory abnormalities
• History of malignant hyperthermia or family history
• Extensive skin burns or injuries
• Seriously infect
• Long term use of nonsteroidal anti-inflammatory drugs
• Expected difficult airway
• Researchers believe that individuals who are not suitable to participate in clinical trial
• Refusal to sign informed consent form
• Withdraw informed consent form
• Severe bleeding or shock during perioperative period.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,323 participants in 4 patient groups

Intraoperative hypothermia low risk group

Experimental group

Description:

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℃).

Treatment:

Other: Measurement of tympanic membrane temperature

Diagnostic Test: Prediction of intraoperative hypothermia risk

Intraoperative hypothermia high risk group

Experimental group

Description:

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 ℃.

Treatment:

Device: Inflatable warming system

Other: Measurement of tympanic membrane temperature

Diagnostic Test: Prediction of intraoperative hypothermia risk

Model optimization group

Other group

Description:

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.

Treatment:

Other: Measurement of tympanic membrane temperature

Other: The difference between axillary temperatature and core temperature in elderly patients

Group of model benefit evaluation

No Intervention group

Description:

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.