Body Temperature Changes, Hypothermia; Anesthesia
Conditions
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.
Interventions
DEVICEIOB Warming Unit (WU505) + Inflatable Warming Blanket
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.
DEVICEcover with a quilt from the neck to both feet
The patient was covered with a quilt from the neck to both feet after entering the operating room.
Sponsors
First Affiliated Hospital of Chongqing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative bleeding volume | up to 24 hours after surgery | Routine intraoperative monitoring indicators |
| 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 |
| 6-month postoperative complications (surgical complications, pulmonary infections, blood clots) | 6 months after surgery | Routine postoperative monitoring indicators |
| 30-day postoperative complications (surgical complications, pulmonary infections, blood clots) | 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 |
| Postoperative coagulation index | up to 24 hours after surgery | Routine intraoperative 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 |
| 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 |
| 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 |
| 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 mortality | 30 days after surgery | Routine postoperative monitoring indicators |
Countries
China
Outcome results
None listed