An interventional study of IOB Warming Unit (WU505) + Inflatable Warming Blanket and cover with a quilt from the neck to both feet in Hypothermia; Anesthesia and Body Temperature Changes, sponsored by First Affiliated Hospital of Chongqing Medical University. Completed at 1 site in China. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2025-07-17.
Sponsored by First Affiliated Hospital of Chongqing Medical University · Not applicable, Interventional, and Prevention
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.
449 studies on the registry are indexed under Hypothermia; 54 are open to participants now.
This study's enrollment of 1,360 is above the median of 77 across 328 interventional studies indexed under Hypothermia.
Browse Hypothermia studies →First Affiliated Hospital of Chongqing Medical University is the lead sponsor of 95 studies on the registry; 42 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: cover with a quilt from the neck to both 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.
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.
The patient was covered with a quilt from the neck to both feet after entering the operating room.
Incidence of intraoperative hypothermia
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.
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
Time frame: up to 60 minutes
Intraoperative bleeding volume
Routine intraoperative monitoring indicators
Time frame: 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.
Time frame: up to 24 hours after surgery
30-day postoperative readmission
Routine postoperative monitoring indicators
Time frame: 30 days after surgery
6-month postoperative complications (surgical complications, pulmonary infections, blood clots)
Routine postoperative monitoring indicators
Time frame: 6 months after surgery
30-day postoperative complications (surgical complications, pulmonary infections, blood clots)
Routine postoperative monitoring indicators
Time frame: 30 days after surgery
30-day postoperative mortality
Routine postoperative monitoring indicators
Time frame: 30 days after surgery
Postoperative coagulation index
Routine intraoperative monitoring indicators
Time frame: up to 24 hours after surgery
Intraoperative blood transfusion volume
Routine intraoperative monitoring indicators, recorded according to intraoperative blood transfusion volume
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 60 minutes
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
First Affiliated Hospital of Chongqing Medical University