Systemic Prevention and Management for Perioperative Hypothermia and Its Effect on Patients Outcome

Study Overview
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Brief Summary
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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.

Official Title
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Establishment of Systemic Prevention and Management for Perioperative Hypothermia and Its Effect on Patients Outcome-a Prospective Multiple Centers Randomized Controlled Study

Conditions
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Hypothermia; Anesthesia

Intervention / Treatment
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* Combination Product: high risk warm
* Combination Product: moderate risk warm
* Combination Product: low risk warm
* Other: passive warming


Participation Criteria
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Eligibility Criteria
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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%

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: control group<br>Cotton Blanket Warming (CBW) starts 30 min preoperatively and then continues throughout the entire operation. | Other: passive warming<br>* cotton blanket warming through operation<br>|
| Experimental: warm group<br>Warm according to different hypothermia risk for low risk ---Forced-air warming(FAW) starts at least 30 min preoperatively and then Cotton Blanket Warming (CBW) continues throughout the entire operation. moderate risk---Forced-air warming(FAW) starts at least 30 min preoperatively and then Cotton Blanket Warming (CBW) and fluid warming continues throughout the entire operation. high risk ----Forced-air warming(FAW) starts at least 30 min preoperatively, FAW and fluid warming continues throughout the entire operation. | Combination Product: high risk warm<br>* Bair HuggerTM Forced-air Warming System to 30min pre- and entire operation warming, combined fluid warming<br>Combination Product: moderate risk warm<br>* 30 min prewarming The Bair HuggerTM Forced-air Warming System cotton blanket warming and fluid warming through operation<br>Combination Product: low risk warm<br>* 30 min prewarming The Bair HuggerTM Forced-air Warming System and cotton blanket warming through operation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of intraoperative hypothermia | Core temperature<36℃ | During operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of Intraoperative blood loss/blood transfusion |  | During operation | 
| 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 | 
| Mini-Mental State Examination (MMSE), | It's a scare to evaluate cognitive function. Total score is 30 . Higher values represent a better cognitive function. | One day preoperation and 1 , 7，30 days postoperation | 
| digit symbol substitution test | 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. | One day preoperation and 1 , 7，30 days postoperation | 
| Auditory Verbal Learning Test, | 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. | One day preoperation and 1 , 7，30 days postoperation | 
| Color Word Stroop Test | 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. | One day preoperation and 1 , 7，30 days postoperation | 
| digit span test. | a memory test that involves remember a series of numbers test short time memory Higher values represent a better memory functions. | One day preoperation and 1 , 7，30 days postoperation | 
| postoperative cognitive dysfunction incidence | 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 | One day preoperation and 1 , 7，30 days postoperation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypothermia