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| Name | Class |
|---|---|
| Xuanwu Hospital, Beijing | OTHER |
| Beijing Hospital | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Sham Comparator | Cotton Blanket Warming (CBW) starts 30 min preoperatively and then continues throughout the entire operation. |
|
| warm group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| high risk warm | Combination Product | Bair HuggerTM Forced-air Warming System to 30min pre- and entire operation warming, combined fluid warming |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of intraoperative hypothermia | Core temperature<36℃ | During operation |
| 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 | |
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Inclusion Criteria:
Age≥18 Core temperature preoperation ≥36.0 ℃ and ≤37.5℃ ASA I-III Informed consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiaxin Lang, doctor | Contact | 13611119094 | langjx09@163.com | |
| Jie Yi, doctor | Contact | 13701362812 | neyil@pumch.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yuguang Huang, doctor | Peking Union Medcial College Hospital | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26360773 | Background | Yi J, Xiang Z, Deng X, Fan T, Fu R, Geng W, Guo R, He N, Li C, Li L, Li M, Li T, Tian M, Wang G, Wang L, Wang T, Wu A, Wu D, Xue X, Xu M, Yang X, Yang Z, Yuan J, Zhao Q, Zhou G, Zuo M, Pan S, Zhan L, Yao M, Huang Y. Incidence of Inadvertent Intraoperative Hypothermia and Its Risk Factors in Patients Undergoing General Anesthesia in Beijing: A Prospective Regional Survey. PLoS One. 2015 Sep 11;10(9):e0136136. doi: 10.1371/journal.pone.0136136. eCollection 2015. | |
| 29066717 |
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There is not a plan to make IPD available.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 20, 2018 | Mar 14, 2019 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2018 | Mar 14, 2019 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| moderate risk warm | Combination Product | 30 min prewarming The Bair HuggerTM Forced-air Warming System cotton blanket warming and fluid warming through operation |
|
| low risk warm | Combination Product | 30 min prewarming The Bair HuggerTM Forced-air Warming System and cotton blanket warming through operation |
|
| passive warming | Other | cotton blanket warming through operation |
|
| 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 |
| One day preoperation and 1 , 7，30 days postoperation |
| Result |
| Yi J, Zhan L, Lei Y, Xu S, Si Y, Li S, Xia Z, Shi Y, Gu X, Yu J, Xu G, Gu E, Yu Y, Chen Y, Jia H, Wang Y, Wang X, Chai X, Jin X, Chen J, Xu M, Xiong J, Wang G, Lu K, Yu W, Lei W, Qin Z, Xiang J, Li L, Yao M, Huang Y. Establishment and Validation of a Prediction Equation to Estimate Risk of Intraoperative Hypothermia in Patients Receiving General Anesthesia. Sci Rep. 2017 Oct 24;7(1):13927. doi: 10.1038/s41598-017-12997-x. |
| 28594825 | Result | Yi J, Lei Y, Xu S, Si Y, Li S, Xia Z, Shi Y, Gu X, Yu J, Xu G, Gu E, Yu Y, Chen Y, Jia H, Wang Y, Wang X, Chai X, Jin X, Chen J, Xu M, Xiong J, Wang G, Lu K, Yu W, Lei W, Qin Z, Xiang J, Li L, Xiang Z, Pan S, Zhan L, Qiu K, Yao M, Huang Y. Intraoperative hypothermia and its clinical outcomes in patients undergoing general anesthesia: National study in China. PLoS One. 2017 Jun 8;12(6):e0177221. doi: 10.1371/journal.pone.0177221. eCollection 2017. |