Hypothermia Risk Prediction Combined With Active Insulation Management in Geriatric Surgery

Chongqing Medical University

Status: Not yet enrolling

Conditions: Body Temperature Changes; Hypothermia; Anesthesia

Treatments: Device: IOB Warming Unit (WU505) + Inflatable Warming Blanket; Device: cover with a quilt from the neck to both feet

Study type: Interventional

Funder types: Other

Identifiers

NCT05430997

BTM-20220608

Details and patient eligibility

About

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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,500 participants in 2 patient groups

Group A: conventional management

Active Comparator group

Description:

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.

Treatment:

Device: cover with a quilt from the neck to both feet

Group B: Hypothermia Risk Prediction Joint Active Insulation Management

Experimental group

Description:

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.

Treatment:

Device: IOB Warming Unit (WU505) + Inflatable Warming Blanket