Hypothermia Risk Prediction Combined With Active Insulation Management in Geriatric Surgery

Not Applicable

Completed

• Conditions: Hypothermia; Anesthesia; Body Temperature Changes

• Registration Number: NCT05430997
• Lead Sponsor: First Affiliated Hospital of Chongqing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2022-06-14
• Study First Submitted QC: 2022-06-18
• Study First Posted: 2022-06-24
• Primary Completion: 2023-07-01
• Study Completion: 2023-08-01
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1360

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of intraoperative hypothermia	Up to 24 hours, from the time of entry into the operating room to the time of exit from the operating room.	Intraoperative hypothermia, defined as a core temperature below 36 °C

Secondary Outcome Measures

Name	Time	Method
Postoperative blood count	up to 24 hours after surgery	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.
30-day postoperative readmission	30 days after surgery	Routine postoperative monitoring indicators
Postoperative coagulation index	up to 24 hours after surgery	Routine intraoperative monitoring indicators
Intraoperative fluid transfusion	15 minutes before the end of the surgery	Routine intraoperative monitoring indicators, the general rehydration amount for surgical patients is 4-6 ml per kilogram of body weight per hour
Shivering severity	60 minutes	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.
Postprocedural Shivering	up to 60 minutes	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
Intraoperative bleeding volume	up to 24 hours after surgery	Routine intraoperative monitoring indicators
6-month postoperative complications (surgical complications, pulmonary infections, blood clots)	6 months after surgery	Routine postoperative monitoring indicators
30-day postoperative mortality	30 days after surgery	Routine postoperative monitoring indicators
Intraoperative blood transfusion volume	15 minutes before the end of the surgery	Routine intraoperative monitoring indicators, recorded according to intraoperative blood transfusion volume
30-day postoperative complications (surgical complications, pulmonary infections, blood clots)	30 days after surgery	Routine postoperative monitoring indicators
intraoperative flushing fluid volume	15 minutes before the end of the surgery	Routine intraoperative monitoring indicators, record the amount of intraoperative irrigation fluid used, depending on the procedure

Trial Locations

Locations (1)

First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, China