Hypothermia; Anesthesia
Conditions
Keywords
hypothermia
Brief summary
This is a randomized, single-blinded, multi-center study clinical trial to determine both clinical and health outcomes of stratified warm strategy to prevent intraoperative hypothermia. Participants enrolled into this trial will be from elective major surgery population in PUMC Hospital, Beijing Hospital and Xuanwu Hospital. investigators plan to enroll approximately 800 participants. Hypothermia risk will be evaluated through PREDICTOR model in all participants. According to hypothermia risk level, these participants will be stratefied into high, moderate and low risk group. Participants in each group will be randomly categorize into warm group and control group. Active warm and fluid warm strategy, prewarm and fluid warm strategy and only prewarm strategy are used for high risk, moderate risk and low risk patients seperately. For controll group traditional passive warm was used.
Interventions
COMBINATION_PRODUCThigh risk warm
Bair HuggerTM Forced-air Warming System to 30min pre- and entire operation warming, combined fluid warming
COMBINATION_PRODUCTmoderate risk warm
30 min prewarming The Bair HuggerTM Forced-air Warming System cotton blanket warming and fluid warming through operation
COMBINATION_PRODUCTlow risk warm
30 min prewarming The Bair HuggerTM Forced-air Warming System and cotton blanket warming through operation
OTHERpassive warming
cotton blanket warming through operation
Sponsors
Xuanwu Hospital, Beijing
Beijing Hospital
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age≥18 Core temperature preoperation ≥36.0 ℃ and ≤37.5℃ ASA I-III Informed consent
Exclusion criteria
* emergency operation * uncontrolled diebete mellitus with insulin treatment （preoperative blood glucose\>250mg/dL） * hyperthyroidism and hypothyroidism * Raynaud's disease * patients with hematopathy and immune disease * anticoagulant and non-steroid anti-inflammatory drug intake with 14 days before operation * infectious fever within 4 weeks before operation * laboratory abnomality as follow * Hemoglobin≤10.0g/L * Platelet≤100,000/ml * White blood cell\<3000/dl or\>14,000/dl * Fibrinogen\<200mg/dL * Thrombin time\>40 second * International normalized ratio\<70%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of intraoperative hypothermia | During operation | Core temperature\<36℃ |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay in PACU | Postoperative during in postanaesthesia care unit， up to 24 hours after surgery | — |
| The incidence of Surgical site infection | WIthin 30 days postoperative | — |
| Lenght of Stay in hospital | impatient period， up to 6 month after surgery | — |
| Lenght of Stay in ICU | impatient period， up to 6 month after surgery | — |
| Incidence of Adverse cardiovascular events | WIthin 6 month post operation | — |
| Incidence of shiver | during in postanaesthesia care unit， up to 24 hours after surgery | — |
| The amount of Intraoperative blood loss/blood transfusion | During operation | — |
| digit symbol substitution test | One day preoperation and 1 , 7，30 days postoperation | The digit symbol substitution test is an evaluation tool used to assess cognitive functioning. It initially was part of the Wechsler Adult Intelligence Test (WAIS), a well-known test that measures an individual's attention. lower digit symbol test scores were correlated with a higher risk of developing dementia in both the five and 10 year groups.Higher values represent a better cognitive function. |
| Auditory Verbal Learning Test, | One day preoperation and 1 , 7，30 days postoperation | a memory test that involves learning verbal material, usually single words presented in a list, that is continually presented over repeated trials. Higher values represent a better memory functions. |
| Color Word Stroop Test | One day preoperation and 1 , 7，30 days postoperation | The Stroop Colour and Word Test (SCWT) is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect. Higher values represent a better ability to inhibit cognitive interference. |
| digit span test. | One day preoperation and 1 , 7，30 days postoperation | a memory test that involves remember a series of numbers test short time memory Higher values represent a better memory functions. |
| postoperative cognitive dysfunction incidence | One day preoperation and 1 , 7，30 days postoperation | * Z score=（postoperative score-preoperative core）/SD of non-surgical group * Two or more than two item in cognitive examination Z score\<-1.96 * Z score=（postoperative score-preoperative core）/SD of non-surgical group Two or more than two item in cognitive examination Z score\<-1.96 |
| Mini-Mental State Examination (MMSE), | One day preoperation and 1 , 7，30 days postoperation | It's a scare to evaluate cognitive function. Total score is 30 . Higher values represent a better cognitive function. |
Contacts
Primary ContactJiaxin Lang, doctor
Backup ContactJie Yi, doctor
Outcome results
None listed