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NCT Number: NCT05430997

Hypothermia Risk Prediction Combined With Active Insulation Management in Geriatric Surgery

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.

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Key information

Conditions

Hypothermia; Anesthesia Body Temperature Changes Hypothermia Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Affiliated Hospital of Chongqing Medical University

Chongqing, 400010, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

IOB Warming Unit (WU505) + Inflatable Warming Blanket

Device

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

Device

The patient was covered with a quilt from the neck to both feet after entering the operating room.

Primary outcomes

  1. Incidence of intraoperative hypothermia

    Time frame: 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 outcomes

  1. Postprocedural Shivering

    Time frame: 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

  2. Intraoperative bleeding volume

    Time frame: up to 24 hours after surgery

    Routine intraoperative monitoring indicators

  3. Postoperative blood count

    Time frame: 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.

  4. 30-day postoperative readmission

    Time frame: 30 days after surgery

    Routine postoperative monitoring indicators

  5. 6-month postoperative complications (surgical complications, pulmonary infections, blood clots)

    Time frame: 6 months after surgery

    Routine postoperative monitoring indicators

  6. 30-day postoperative complications (surgical complications, pulmonary infections, blood clots)

    Time frame: 30 days after surgery

    Routine postoperative monitoring indicators

  7. 30-day postoperative mortality

    Time frame: 30 days after surgery

    Routine postoperative monitoring indicators

  8. Postoperative coagulation index

    Time frame: up to 24 hours after surgery

    Routine intraoperative monitoring indicators

  9. Intraoperative blood transfusion volume

    Time frame: 15 minutes before the end of the surgery

    Routine intraoperative monitoring indicators, recorded according to intraoperative blood transfusion volume

  10. Intraoperative fluid transfusion

    Time frame: 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

  11. intraoperative flushing fluid volume

    Time frame: 15 minutes before the end of the surgery

    Routine intraoperative monitoring indicators, record the amount of intraoperative irrigation fluid used, depending on the procedure

  12. Shivering severity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Chongqing Medical University

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 24, 2022
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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