Hypothermia; AnesthesiaNCT05430997
Hypothermia Risk Prediction Combined With Active Insulation Management in Geriatric Surgery
A study testing IOB Warming Unit (WU505) + Inflatable Warming Blanket and cover with a quilt from the neck to both feet in people with Hypothermia; Anesthesia and Body Temperature Changes, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hypothermia; Anesthesia, Body Temperature Changes
- What is being tested?
- IOB Warming Unit (WU505) + Inflatable Warming Blanket and cover with a quilt from the neck to both feet
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,360 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Chongqing Medical University
Chongqing, 400010
About this study
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
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.
- Conditions
- Hypothermia; Anesthesia, Body Temperature Changes
- Being tested
- IOB Warming Unit (WU505) + Inflatable Warming Blanket, cover with a quilt from the neck to both feet
- Medical subject headings
- Hypothermia, Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOB Warming Unit (WU505) + Inflatable Warming BlanketDevice
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 feetDevice
The patient was covered with a quilt from the neck to both feet after entering the operating room.
| Study group | Role | What they receive |
|---|---|---|
| Group A: conventional management | Active comparator | 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. Receives: Device: cover with a quilt from the neck to both feet |
| Group B: Hypothermia Risk Prediction Joint Active Insulation Management | Experimental | 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. Receives: Device: IOB Warming Unit (WU505) + Inflatable Warming Blanket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intraoperative hypothermia
Intraoperative hypothermia, defined as a core temperature below 36 °C
Measured: Up to 24 hours, from the time of entry into the operating room to the time of exit from the operating room.
Secondary outcomes (12)
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
Measured: up to 60 minutes
Intraoperative bleeding volume
Routine intraoperative monitoring indicators
Measured: up to 24 hours after surgery
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.
Measured: up to 24 hours after surgery
30-day postoperative readmission
Routine postoperative monitoring indicators
Measured: 30 days after surgery
6-month postoperative complications (surgical complications, pulmonary infections, blood clots)
Routine postoperative monitoring indicators
Measured: 6 months after surgery
30-day postoperative complications (surgical complications, pulmonary infections, blood clots)
Routine postoperative monitoring indicators
Measured: 30 days after surgery
30-day postoperative mortality
Routine postoperative monitoring indicators
Measured: 30 days after surgery
Postoperative coagulation index
Routine intraoperative monitoring indicators
Measured: up to 24 hours after surgery
Intraoperative blood transfusion volume
Routine intraoperative monitoring indicators, recorded according to intraoperative blood transfusion volume
Measured: 15 minutes before the end of the surgery
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
Measured: 15 minutes before the end of the surgery
intraoperative flushing fluid volume
Routine intraoperative monitoring indicators, record the amount of intraoperative irrigation fluid used, depending on the procedure
Measured: 15 minutes before the end of the surgery
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.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start1 Jun 2022
- Primary completion1 Jul 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypothermia; AnesthesiaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Chongqing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,360 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Su, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430997
- Sponsor's protocol ID
- BTM-20220608
- Status last verified
- Jul 2025
- First submitted
- 14 Jun 2022
- Last updated
- 17 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05430997
- Acronym / sponsor ID
- BTM-20220608
- Conditions
- Hypothermia; Anesthesia, Body Temperature Changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,360 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 24 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: conventional management | Active comparator | Device: cover with a quilt from the neck to both feetThe 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 | Experimental | Device: IOB Warming Unit (WU505) + Inflatable Warming BlanketIn 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IOB Warming Unit (WU505) + Inflatable Warming BlanketThe 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. | Device | Group B: Hypothermia Risk Prediction Joint Active Insulation Management |
| cover with a quilt from the neck to both feetThe patient was covered with a quilt from the neck to both feet after entering the operating room. | Device | Group A: conventional management |
Primary outcome
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
12 secondary outcomes
Postprocedural Shivering
Time frame: up to 60 minutes
Intraoperative bleeding volume
Time frame: up to 24 hours after surgery
Postoperative blood count
Time frame: up to 24 hours after surgery
30-day postoperative readmission
Time frame: 30 days after surgery
6-month postoperative complications (surgical complications, pulmonary infections, blood clots)
Time frame: 6 months after surgery
30-day postoperative complications (surgical complications, pulmonary infections, blood clots)
Time frame: 30 days after surgery
30-day postoperative mortality
Time frame: 30 days after surgery
Postoperative coagulation index
Time frame: up to 24 hours after surgery
Intraoperative blood transfusion volume
Time frame: 15 minutes before the end of the surgery
Intraoperative fluid transfusion
Time frame: 15 minutes before the end of the surgery
intraoperative flushing fluid volume
Time frame: 15 minutes before the end of the surgery
Shivering severity
Time frame: 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Individual participant dataSharing planned: No
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Goal-Directed Temperature Management During Prolonged Abdominal Surgery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IOB Warming Unit (WU505) + Inflatable Warming Blanket and cover with a quilt from the neck to both feet in people with Hypothermia; Anesthesia and Body Temperature Changes, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.