Clinical trial NCT05430997: Hypothermia Risk Prediction Combined With Active Insulation Management in Geriatric Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypothermia; Anesthesia
Body Temperature Changes
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 1500
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Incidence of intraoperative hypothermia
timeFrame: Up to 24 hours, from the time of entry into the operating room to the time of exit from the operating room.
Secondary outcomes:
measure: Postprocedural Shivering
timeFrame: up to 60 minutes
measure: Intraoperative bleeding volume
timeFrame: up to 24 hours after surgery
measure: Postoperative blood count
timeFrame: up to 24 hours after surgery
measure: 30-day postoperative readmission
timeFrame: 30 days after surgery
measure: 6-month postoperative complications (surgical complications, pulmonary infections, blood clots)
timeFrame: 6 months after surgery
measure: 30-day postoperative complications (surgical complications, pulmonary infections, blood clots)
timeFrame: 30 days after surgery
measure: 30-day postoperative mortality
timeFrame: 30 days after surgery
measure: Postoperative coagulation index
timeFrame: up to 24 hours after surgery
measure: Intraoperative blood transfusion volume
timeFrame: 15 minutes before the end of the surgery
measure: Intraoperative fluid transfusion
timeFrame: 15 minutes before the end of the surgery
measure: intraoperative flushing fluid volume
timeFrame: 15 minutes before the end of the surgery
measure: Shivering severity
timeFrame: 60 minutes
Other outcomes:
Locations:
Study officials:
References: