Clinical trial NCT06676735: Research on Intraoperative Hypothermia Risk Prediction Model and Temperature Management Strategy for Elderly Patients During Surgery Based on Dynamic Incremental Training
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intraoperative Hypothermia
Keywords: Intraoperative hypothermia
Prediction model
Elderly patients
Active warming
Machine Learning
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2024-11-06
Enrollment: 2424
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 criteria: Inclusion Criteria:

* 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

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.

Primary outcomes:
measure: Intraoperative hypothermia
timeFrame: Up to 24 hours, from the time of entry into the operating room to the time of exit from the operating room.
Secondary outcomes:
measure: The specificity and sensitivity of the model
timeFrame: 1 year
measure: Physical sensation
timeFrame: Perioperative period
measure: Total volume of intraoperative blood loss
timeFrame: Intraoperative
measure: Postoperative shivering
timeFrame: Up to 60 minutes
measure: Postoperative coagulation index
timeFrame: Within 24 hours after operation
measure: Postoperative hospital stay
timeFrame: Through study completion, an average of 1 year
measure: Total hospital stay
timeFrame: Through study completion, an average of 1 year
measure: Costs of using active warming
timeFrame: Perioperative period
measure: Postoperative hospital costs
timeFrame: Through study completion, an average of 1 year
measure: Total hospital costs
timeFrame: Through study completion, an average of 1 year
measure: 30-day postoperative readmission
timeFrame: 30 days after operation
measure: 30-day postoperative complications
timeFrame: 30 days after operation
measure: 30-day postoperative mortality
timeFrame: 30 days after operation
measure: Heart rate
timeFrame: Perioperative period
measure: Blood pressure
timeFrame: Perioperative period
measure: Blood oxygen saturation
timeFrame: Perioperative period
Other outcomes:
Locations:
city: Chongqing
country: China
facility: First Affiliated Hospital of Chongqing Medical University
state: 重庆市
Study officials:
References: