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Hypothermia Risk Prediction Combined With Active Insulation Management in Geriatric Surgery

Primary Purpose

Hypothermia; Anesthesia, Body Temperature Changes

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
IOB Warming Unit (WU505) + Inflatable Warming Blanket
cover with a quilt from the neck to both feet
Sponsored by
First Affiliated Hospital of Chongqing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypothermia; Anesthesia

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Group A: conventional management

    Group B: Hypothermia Risk Prediction Joint Active Insulation Management

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Incidence of intraoperative hypothermia
    Intraoperative hypothermia, defined as a core temperature below 36 °C

    Secondary Outcome Measures

    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
    Intraoperative bleeding volume
    Routine intraoperative monitoring indicators
    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.
    30-day postoperative readmission
    Routine postoperative monitoring indicators
    6-month postoperative complications (surgical complications, pulmonary infections, blood clots)
    Routine postoperative monitoring indicators
    30-day postoperative complications (surgical complications, pulmonary infections, blood clots)
    Routine postoperative monitoring indicators
    30-day postoperative mortality
    Routine postoperative monitoring indicators
    Postoperative coagulation index
    Routine intraoperative monitoring indicators
    Intraoperative blood transfusion volume
    Routine intraoperative monitoring indicators, recorded according to intraoperative blood transfusion volume
    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
    intraoperative flushing fluid volume
    Routine intraoperative monitoring indicators, record the amount of intraoperative irrigation fluid used, depending on the procedure
    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.

    Full Information

    First Posted
    June 14, 2022
    Last Updated
    June 18, 2022
    Sponsor
    First Affiliated Hospital of Chongqing Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05430997
    Brief Title
    Hypothermia Risk Prediction Combined With Active Insulation Management in Geriatric Surgery
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2022 (Anticipated)
    Primary Completion Date
    March 1, 2023 (Anticipated)
    Study Completion Date
    July 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    First Affiliated Hospital of Chongqing Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypothermia; Anesthesia, Body Temperature Changes

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A: conventional management
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Group B: Hypothermia Risk Prediction Joint Active Insulation Management
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    IOB Warming Unit (WU505) + Inflatable Warming Blanket
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    cover with a quilt from the neck to both feet
    Intervention Description
    The patient was covered with a quilt from the neck to both feet after entering the operating room.
    Primary Outcome Measure Information:
    Title
    Incidence of intraoperative hypothermia
    Description
    Intraoperative hypothermia, defined as a core temperature below 36 °C
    Time Frame
    Up to 24 hours, from the time of entry into the operating room to the time of exit from the operating room.
    Secondary Outcome Measure Information:
    Title
    Postprocedural Shivering
    Description
    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
    Time Frame
    up to 60 minutes
    Title
    Intraoperative bleeding volume
    Description
    Routine intraoperative monitoring indicators
    Time Frame
    up to 24 hours after surgery
    Title
    Postoperative blood count
    Description
    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.
    Time Frame
    up to 24 hours after surgery
    Title
    30-day postoperative readmission
    Description
    Routine postoperative monitoring indicators
    Time Frame
    30 days after surgery
    Title
    6-month postoperative complications (surgical complications, pulmonary infections, blood clots)
    Description
    Routine postoperative monitoring indicators
    Time Frame
    6 months after surgery
    Title
    30-day postoperative complications (surgical complications, pulmonary infections, blood clots)
    Description
    Routine postoperative monitoring indicators
    Time Frame
    30 days after surgery
    Title
    30-day postoperative mortality
    Description
    Routine postoperative monitoring indicators
    Time Frame
    30 days after surgery
    Title
    Postoperative coagulation index
    Description
    Routine intraoperative monitoring indicators
    Time Frame
    up to 24 hours after surgery
    Title
    Intraoperative blood transfusion volume
    Description
    Routine intraoperative monitoring indicators, recorded according to intraoperative blood transfusion volume
    Time Frame
    15 minutes before the end of the surgery
    Title
    Intraoperative fluid transfusion
    Description
    Routine intraoperative monitoring indicators, the general rehydration amount for surgical patients is 4-6 ml per kilogram of body weight per hour
    Time Frame
    15 minutes before the end of the surgery
    Title
    intraoperative flushing fluid volume
    Description
    Routine intraoperative monitoring indicators, record the amount of intraoperative irrigation fluid used, depending on the procedure
    Time Frame
    15 minutes before the end of the surgery
    Title
    Shivering severity
    Description
    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.
    Time Frame
    60 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Learn more about this trial

    Hypothermia Risk Prediction Combined With Active Insulation Management in Geriatric Surgery

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