Hypothermia Risk Prediction Combined With Active Insulation Management in Geriatric Surgery

Hypothermia; Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05430997
• Other study ID #: BTM-20220608
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: June 2022
• Source: First Affiliated Hospital of Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: July 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Body Temperature Changes
• Hypothermia
• Hypothermia; Anesthesia

Intervention

Device:
• IOB 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.
• cover 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Chongqing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of intraoperative hypothermia	Intraoperative hypothermia, defined as a core temperature below 36 °C	Up to 24 hours, from the time of entry into the operating room to the time of exit from the operating room.
Secondary	Postprocedural Shivering	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	up to 60 minutes
Secondary	Intraoperative bleeding volume	Routine intraoperative monitoring indicators	up to 24 hours after surgery
Secondary	Postoperative blood count	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.	up to 24 hours after surgery
Secondary	30-day postoperative readmission	Routine postoperative monitoring indicators	30 days after surgery
Secondary	6-month postoperative complications (surgical complications, pulmonary infections, blood clots)	Routine postoperative monitoring indicators	6 months after surgery
Secondary	30-day postoperative complications (surgical complications, pulmonary infections, blood clots)	Routine postoperative monitoring indicators	30 days after surgery
Secondary	30-day postoperative mortality	Routine postoperative monitoring indicators	30 days after surgery
Secondary	Postoperative coagulation index	Routine intraoperative monitoring indicators	up to 24 hours after surgery
Secondary	Intraoperative blood transfusion volume	Routine intraoperative monitoring indicators, recorded according to intraoperative blood transfusion volume	15 minutes before the end of the surgery
Secondary	Intraoperative fluid transfusion	Routine intraoperative monitoring indicators, the general rehydration amount for surgical patients is 4-6 ml per kilogram of body weight per hour	15 minutes before the end of the surgery
Secondary	intraoperative flushing fluid volume	Routine intraoperative monitoring indicators, record the amount of intraoperative irrigation fluid used, depending on the procedure	15 minutes before the end of the surgery
Secondary	Shivering severity	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.	60 minutes