Hypothermia Risk Prediction Combined With Active Insulation Management in Geriatric Surgery

NCT05430997 | Completed

• 1 other identifier: BTM-20220608
• Study Type: interventional
• Target: 1,360
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Postprocedural Shivering

  up to 60 minutes

• Intraoperative bleeding volume

  up to 24 hours after surgery

• Postoperative blood count

  up to 24 hours after surgery

• 30-day postoperative readmission

  30 days after surgery

• 6-month postoperative complications (surgical complications, pulmonary infections, blood clots)

  6 months after surgery

Study Arms (2)

Group A: conventional management

ACTIVE COMPARATOR

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

Group B: Hypothermia Risk Prediction Joint Active Insulation Management

EXPERIMENTAL

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

Interventions

IOB Warming Unit (WU505) + Inflatable Warming Blanket 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.

Group B: Hypothermia Risk Prediction Joint Active Insulation Management

cover with a quilt from the neck to both feet DEVICE

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

Group A: conventional management

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Mental illness.
• 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).
• Impaired skin insulation barriers such as large skin burns.
• Infectious fever.
• Other causes of body temperature above 38.5 °C three days before surgery.
• Other persons deemed unsuitable by the investigator to participate in the clinical trial.
• Refusal to sign the informed consent form.

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

First Affiliated Hospital of Chongqing Medical University

Chongqing, 400010, China

Location

MeSH Terms

Conditions

Hypothermia; Body Temperature Changes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor.Min

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 24, 2022
• Study Start: June 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: August 1, 2023
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)