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Completed

NCT Number: NCT06676735

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

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.

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Key information

Conditions

Intraoperative Hypothermia

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 ℃.

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.

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).

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.

Primary outcomes

  1. Intraoperative hypothermia

    Time frame: Up to 24 hours, from the time of entry into the operating room to the time of exit from the operating room.

    Intraoperative hypothermia, defined as a core temperature below 36 °C

Secondary outcomes

  1. The specificity and sensitivity of the model

    Time frame: 1 year

    Conventional parameters for evaluating model accuracy

  2. Physical sensation

    Time frame: Perioperative period

    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)

  3. Total volume of intraoperative blood loss

    Time frame: Intraoperative

    Routine intraoperative monitoring indicators

  4. Postoperative shivering

    Time frame: Up to 60 minutes

    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.

  5. Postoperative coagulation index

    Time frame: Within 24 hours after operation

    Routine postoperative monitoring indicators

  6. Postoperative hospital stay

    Time frame: Through study completion, an average of 1 year

    The number of days from the end of surgery to discharge displayed in the electronic medical record system for patients

  7. Total hospital stay

    Time frame: Through study completion, an average of 1 year

    The number of days from admission to discharge displayed in the electronic medical record system for patients.

  8. Costs of using active warming

    Time frame: Perioperative period

  9. Postoperative hospital costs

    Time frame: Through study completion, an average of 1 year

    The Postoperative hospital cost (￥) from the end of surgery to discharge displayed in the electronic medical record system

  10. Total hospital costs

    Time frame: Through study completion, an average of 1 year

    The Total hospital cost (￥) from admission to discharge displayed in the electronic medical record system

  11. 30-day postoperative readmission

    Time frame: 30 days after operation

    Routine postoperative monitoring indicators

  12. 30-day postoperative complications

    Time frame: 30 days after operation

    Routine postoperative monitoring indicators

  13. 30-day postoperative mortality

    Time frame: 30 days after operation

    Routine postoperative monitoring indicators

  14. Heart rate

    Time frame: Perioperative period

    Obtained from multi parameter monitor

  15. Blood pressure

    Time frame: Perioperative period

    Obtained from multi parameter monitor

  16. Blood oxygen saturation

    Time frame: Perioperative period

    Obtained from multi parameter monitor

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Chongqing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Nov 6, 2024
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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