Hypothermia Risk Prediction Combined With Active Insulation Management in Geriatric Surgery

NCT ID: NCT05430997

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-08-01

Brief Summary

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.

Conditions

Hypothermia; Anesthesia; Body Temperature Changes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

cover with a quilt from the neck to both feet

Intervention Type: DEVICE

The patient was covered with a quilt from the neck to both feet after entering the operating room.

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.

Group Type: EXPERIMENTAL

IOB Warming Unit (WU505) + Inflatable Warming Blanket

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Min Su

Professor.Min

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

First Affiliated Hospital of Chongqing Medical University

Chongqing, , China

Countries

China

Other Identifiers

BTM-20220608

Identifier Type: -

Identifier Source: org_study_id