Hypothermia Risk Prediction Combined With Active Insulation Management in Geriatric Surgery

July 14, 2025 updated by: Min Su, First Affiliated Hospital of Chongqing Medical University

Hypothermia Risk Prediction Combined With Active Insulation Management in the Burden of Disease Study in Geriatric Surgery: A Multicenter, Randomized, Controlled Study Based on 24 Hospitals in Southwest China

To evaluate the effectiveness and safety of hypothermia risk prediction combined with active warming management to reduce intraoperative hypothermia in elderly patients undergoing elective general anesthesia, improve the quality of anesthesia management, and enhance patients' awareness of the work of anesthesiologists.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1360

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Chongqing, China, 400010
        • First Affiliated Hospital of Chongqing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 60 years, male or female.
  2. Elective general anesthesia for surgery.
  3. Operative time ≥ 30 min.
  4. Preoperative body temperature within the normal range.
  5. Normal preoperative bleeding and clotting time.

Exclusion Criteria:

  1. Mental illness.
  2. High or low basal hypothermia with high or low metabolic disease (patients with central hyperthermia include those with cerebrovascular vascular disease, traumatic brain injury and brain surgery, epilepsy, central hyperthermia due to acute hydrocephalus; thermoregulatory abnormalities including malignant hyperthermia (MHS), neuroleptic malignant syndrome and those with definite evidence of diagnosed hypo- or hyperthyroidism and current abnormal thyroid function).
  3. Impaired skin insulation barriers such as large skin burns.
  4. Infectious fever.
  5. Other causes of body temperature above 38.5 °C three days before surgery.
  6. Other persons deemed unsuitable by the investigator to participate in the clinical trial.
  7. Refusal to sign the informed consent form.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group A: conventional management
The ambient temperature of the operating room was set at 23±2 ℃ and the relative humidity was 50% to 60%. Intraoperative infusion fluids, blood products and rinsing fluid were warmed. Patients were given quilts to cover after entering the operating room, and the quilts covered from the neck to both the feet.
Device: cover with a quilt from the neck to both feet
The patient was covered with a quilt from the neck to both feet after entering the operating room.
Experimental: Group B: Hypothermia Risk Prediction Joint Active Insulation Management
In the test group, after the assessment of the "Intraoperative Hypothermia Risk Prediction APP", patients who were "prompted/recommended to use active warming measures" were actively warmed by inflatable warming (IOB Warming Unit (WU505) + Inflatable Warming Blanket) after admission to the room. Warming Unit (WU505) + Warming Blanket (IOB Warming Blanket)) was used for active warming. The air inlet was connected to the air catheter, and the host temperature was set at 38 ℃ with "high" air speed. During the operation, the thermal blanket is covered with non-surgical sterilization area (such as both shoulders, torso, healthy limbs, etc.), and the host temperature is adjusted to 38 ℃ for thermal insulation. The temperature and wind speed were adjusted in time to maintain the oropharyngeal temperature at 36.2℃～37.2℃ by monitoring the body temperature at any time during the operation.
Device: IOB Warming Unit (WU505) + Inflatable Warming Blanket
The inflatable warming method (Inflatable Warming Unit (IOB Warming Unit, WU505) + Inflatable Warming Blanket (IOB Warming Blanket)) is a common clinical warming technique in anesthesiology, which is well tolerated by patients and safe and effective. The anesthesiology department has established standard operating procedures for the above-mentioned non-invasive operations.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of 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
Up to 24 hours, from the time of entry into the operating room to the time of exit from the operating room.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postprocedural Shivering
Time Frame: up to 60 minutes
A compensatory response of the body to hypothermic stimuli that cause rapid rhythmic，Once the procedure 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. contraction of skeletal muscle for thermogenesis
up to 60 minutes
Intraoperative bleeding volume
Time Frame: up to 24 hours after surgery
Routine intraoperative monitoring indicators
up to 24 hours after surgery
Postoperative blood count
Time Frame: up to 24 hours after surgery
The number of red blood cells, white blood cells and platelets in the blood is calculated by smearing the blood in a routine blood test and looking at it under the microscope.
up to 24 hours after surgery
30-day postoperative readmission
Time Frame: 30 days after surgery
Routine postoperative monitoring indicators
30 days after surgery
6-month postoperative complications (surgical complications, pulmonary infections, blood clots)
Time Frame: 6 months after surgery
Routine postoperative monitoring indicators
6 months after surgery
30-day postoperative complications (surgical complications, pulmonary infections, blood clots)
Time Frame: 30 days after surgery
Routine postoperative monitoring indicators
30 days after surgery
30-day postoperative mortality
Time Frame: 30 days after surgery
Routine postoperative monitoring indicators
30 days after surgery
Postoperative coagulation index
Time Frame: up to 24 hours after surgery
Routine intraoperative monitoring indicators
up to 24 hours after surgery
Intraoperative blood transfusion volume
Time Frame: 15 minutes before the end of the surgery
Routine intraoperative monitoring indicators, recorded according to intraoperative blood transfusion volume
15 minutes before the end of the surgery
Intraoperative fluid transfusion
Time Frame: 15 minutes before the end of the surgery
Routine intraoperative monitoring indicators, the general rehydration amount for surgical patients is 4-6 ml per kilogram of body weight per hour
15 minutes before the end of the surgery
intraoperative flushing fluid volume
Time Frame: 15 minutes before the end of the surgery
Routine intraoperative monitoring indicators, record the amount of intraoperative irrigation fluid used, depending on the procedure
15 minutes before the end of the surgery
Shivering severity
Time Frame: 60 minutes
The post operative shivering scale of Badjatia 2008 will be used. It consist of a gradual evaluation of 0 to 3 points, with 0 being the absence of shivering, 1 slight shivering, 2 moderate and 3 severe. The highest score obtained will be recorded within the measurements made every 5 minutes in the first 60 minutes after extubation.
60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital of Chongqing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BTM-20220608

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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