Hypothermia Risk Prediction Combined With Active Insulation Management in Geriatric Surgery

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: Completed
• Conditions: Body Temperature Changes; Hypothermia; Anesthesia
• Intervention / Treatment: Device: cover with a quilt from the neck to both feet; Device: IOB Warming Unit (WU505) + Inflatable Warming Blanket

• Study Type: Interventional
• Enrollment (Actual): 1360
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Incidence of intraoperative hypothermia	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

Outcome Measure	Measure Description	Time Frame
Postprocedural Shivering	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	Routine intraoperative monitoring indicators	up to 24 hours after surgery
Postoperative blood count	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	Routine postoperative monitoring indicators	30 days after surgery
6-month postoperative complications (surgical complications, pulmonary infections, blood clots)	Routine postoperative monitoring indicators	6 months after surgery
30-day postoperative complications (surgical complications, pulmonary infections, blood clots)	Routine postoperative monitoring indicators	30 days after surgery
30-day postoperative mortality	Routine postoperative monitoring indicators	30 days after surgery
Postoperative coagulation index	Routine intraoperative monitoring indicators	up to 24 hours after surgery
Intraoperative blood transfusion volume	Routine intraoperative monitoring indicators, recorded according to intraoperative blood transfusion volume	15 minutes before the end of the surgery
Intraoperative fluid transfusion	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	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	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

• Sponsor: First Affiliated Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: June 14, 2022
• First Submitted That Met QC Criteria: June 18, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Actual): July 17, 2025
• Last Update Submitted That Met QC Criteria: July 14, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypothermia; Body Temperature Changes
• Other Study ID 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