Intraoperative HypothermiaNCT06676735
Research on Intraoperative Hypothermia Risk Prediction Model and Temperature Management Strategy for Elderly Patients During Surgery Based on Dynamic Incremental Training
A study testing Inflatable warming system, Prediction of intraoperative hypothermia risk and The difference between axillary temperatature and core temperature in elderly patients in people with Intraoperative Hypothermia, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intraoperative Hypothermia
- What is being tested?
- Inflatable warming system, Prediction of intraoperative hypothermia risk and The difference between axillary temperatature and core temperature in elderly patients
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,323 participants
- Where
- 1 siteChina
- Study dates
- 11 Mar 2025to 14 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Mental illness
- Cirrhosis
- Existence or potential central hyperthermia
- Metabolic thermoregulatory abnormalities
- History of malignant hyperthermia or family history
- Extensive skin burns or injuries
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
About this study
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
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:
- 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.
- 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.
- Pre and post comparative study: Collect data before ICE application and compare it with data after ICE promotion.
- Conditions
- Intraoperative Hypothermia
- Being tested
- Inflatable warming system, Prediction of intraoperative hypothermia risk, The difference between axillary temperatature and core temperature in elderly patients, Measurement of tympanic membrane temperature
- Keywords
- Intraoperative hypothermia, Prediction model, Elderly patients, Active warming, Machine Learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inflatable warming systemDevice
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 riskDiagnostic 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 patientsOther
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 temperatureOther
As a intraoperative core temperature reference (measure every 15 minutes) for patients without esophageal temperature or nasopharyngeal temperature monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative hypothermia low risk group | Experimental | 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℃). Receives: Diagnostic Test: Prediction of intraoperative hypothermia risk; Other: Measurement of tympanic membrane temperature |
| Intraoperative hypothermia high risk group | Experimental | 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 ℃. Receives: Device: Inflatable warming system; Diagnostic Test: Prediction of intraoperative hypothermia risk; Other: Measurement of tympanic membrane temperature |
| Model optimization group | Other | 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. Receives: Other: The difference between axillary temperatature and core temperature in elderly patients; Other: Measurement of tympanic membrane temperature |
| Group of model benefit evaluation | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative hypothermia
Intraoperative hypothermia, defined as a core temperature below 36 °C
Measured: Up to 24 hours, from the time of entry into the operating room to the time of exit from the operating room.
Secondary outcomes (16)
The specificity and sensitivity of the model
Conventional parameters for evaluating model accuracy
Measured: 1 year
Physical sensation
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)
Measured: Perioperative period
Total volume of intraoperative blood loss
Routine intraoperative monitoring indicators
Measured: Intraoperative
Postoperative shivering
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.
Measured: Up to 60 minutes
Postoperative coagulation index
Routine postoperative monitoring indicators
Measured: Within 24 hours after operation
Postoperative hospital stay
The number of days from the end of surgery to discharge displayed in the electronic medical record system for patients
Measured: Through study completion, an average of 1 year
Total hospital stay
The number of days from admission to discharge displayed in the electronic medical record system for patients.
Measured: Through study completion, an average of 1 year
Costs of using active warming
Measured: Perioperative period
Postoperative hospital costs
The Postoperative hospital cost (￥) from the end of surgery to discharge displayed in the electronic medical record system
Measured: Through study completion, an average of 1 year
Total hospital costs
The Total hospital cost (￥) from admission to discharge displayed in the electronic medical record system
Measured: Through study completion, an average of 1 year
30-day postoperative readmission
Routine postoperative monitoring indicators
Measured: 30 days after operation
30-day postoperative complications
Routine postoperative monitoring indicators
Measured: 30 days after operation
30-day postoperative mortality
Routine postoperative monitoring indicators
Measured: 30 days after operation
Heart rate
Obtained from multi parameter monitor
Measured: Perioperative period
Blood pressure
Obtained from multi parameter monitor
Measured: Perioperative period
Blood oxygen saturation
Obtained from multi parameter monitor
Measured: Perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start11 Mar 2025
- Primary completion15 Dec 2025
- Study completion14 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative HypothermiaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Chongqing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,323 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Su, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676735
- Sponsor's protocol ID
- ZZ2024-173-01
- Status last verified
- Jan 2026
- First submitted
- 31 Oct 2024
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data Data available: Yes Data types: Identified participant data How to access data: atpcr7@yeah.net When available: Within 5years after this trial Supporting Documents Document types: None Additional Information Who can access the data: Researchers whose proposed use of the data have been approved by Leader Sponsor and Principal Investigator of this trial. Types of analyses: To be discussed with the steering committee. Mechanisms of data availability: With investigator support after approval signed data access agreement. Any additional restrictions: None
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06676735
- Acronym / sponsor ID
- ZZ2024-173-01
- Conditions
- Intraoperative Hypothermia
- Keywords
- Intraoperative hypothermia, Prediction model, Elderly patients, Active warming, Machine Learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,323 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 14 Jan 2026 (actual)
- First posted
- 6 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- Pre and post comparative study: Collect data before ICE application and compare it with data after ICE promotion.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intraoperative hypothermia low risk group | Experimental | Diagnostic Test: Prediction of intraoperative hypothermia risk, Other: Measurement of tympanic membrane temperaturePatients 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℃). |
| Intraoperative hypothermia high risk group | Experimental | Device: Inflatable warming system, Diagnostic Test: Prediction of intraoperative hypothermia risk, Other: Measurement of tympanic membrane temperaturePatients 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 ℃. |
| Model optimization group | Other | Other: The difference between axillary temperatature and core temperature in elderly patients, Other: Measurement of tympanic membrane temperatureOnly 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. |
| Group of model benefit evaluation | No intervention | –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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- Mental illness
- Cirrhosis
- Existence or potential central hyperthermia
- Metabolic thermoregulatory abnormalities
- History of malignant hyperthermia or family history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inflatable warming systemInflatable 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 ℃. | Device | Intraoperative hypothermia high risk group |
| Prediction of intraoperative hypothermia riskAccording 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. | Diagnostic test | Intraoperative hypothermia high risk group, Intraoperative hypothermia low risk group |
| The difference between axillary temperatature and core temperature in elderly patientsPrevious 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 | Model optimization group |
| Measurement of tympanic membrane temperatureAs a intraoperative core temperature reference (measure every 15 minutes) for patients without esophageal temperature or nasopharyngeal temperature monitoring. | Other | Intraoperative hypothermia high risk group, Intraoperative hypothermia low risk group, Model optimization group |
Primary outcome
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
16 secondary outcomes
The specificity and sensitivity of the model
Time frame: 1 year
Physical sensation
Time frame: Perioperative period
Total volume of intraoperative blood loss
Time frame: Intraoperative
Postoperative shivering
Time frame: Up to 60 minutes
Postoperative coagulation index
Time frame: Within 24 hours after operation
Postoperative hospital stay
Time frame: Through study completion, an average of 1 year
Total hospital stay
Time frame: Through study completion, an average of 1 year
Costs of using active warming
Time frame: Perioperative period
Postoperative hospital costs
Time frame: Through study completion, an average of 1 year
Total hospital costs
Time frame: Through study completion, an average of 1 year
30-day postoperative readmission
Time frame: 30 days after operation
30-day postoperative complications
Time frame: 30 days after operation
30-day postoperative mortality
Time frame: 30 days after operation
Heart rate
Time frame: Perioperative period
Blood pressure
Time frame: Perioperative period
Blood oxygen saturation
Time frame: Perioperative period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: Yes. Data Data available: Yes Data types: Identified participant data How to access data: atpcr7@yeah.net When available: Within 5years after this trial Supporting Documents Document types: None Additional Information Who can access the data: Researchers whose proposed use of the data have been approved by Leader Sponsor and Principal Investigator of this trial. Types of analyses: To be discussed with the steering committee. Mechanisms of data availability: With investigator support after approval signed data access agreement. Any additional restrictions: None
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inflatable warming system, Prediction of intraoperative hypothermia risk and The difference between axillary temperatature and core temperature in elderly patients in people with Intraoperative Hypothermia, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.