Hypothermia Risk Prediction Combined With Active Insulation Management in Geriatric Surgery
- Conditions
- Hypothermia; AnesthesiaBody Temperature Changes
- Interventions
- Device: cover with a quilt from the neck to both feetDevice: IOB Warming Unit (WU505) + Inflatable Warming Blanket
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1500
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A: conventional management cover with a quilt from the neck to both feet 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 B: Hypothermia Risk Prediction Joint Active Insulation Management IOB Warming Unit (WU505) + Inflatable Warming Blanket 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.
- 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 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.
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
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
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