电针对颅脑创伤患者围术期肺保护作用的临床研究

注册号:

Registration number:

AMCTR-IPR-20000343 

注册号获得时间:

Date of releasing the registration number:

2020/7/30 9:11:53 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

电针对颅脑创伤患者围术期肺保护作用的临床研究 

Public title:

The clinical study of electroacupuncture on perioperative lung protection in patients with craniocerebral trauma 

研究课题的正式科学名称:

电针对颅脑创伤患者围术期肺保护作用的临床研究 

Scientific title:

The clinical study of electroacupuncture on perioperative lung protection in patients with craniocerebral trauma 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

谭彬彬 

研究负责人:

陈君 

Applicant:

Tan Binbin 

Study leader:

Chen Jun 

申请注册联系人电话:

Applicant telephone:

13820187525 

研究负责人电话:

Study leader's telephone:

13820187525 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

bibli0417@163.com 

研究负责人电子邮件:

Study leader's E-mail:

bibli0417@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

天津市津南区吉兆路6号 

研究负责人通讯地址:

天津市津南区吉兆路6号 

Applicant address:

No. 6, Jizhao Road, Jinnan District, Tianjin 

Study leader's address:

No. 6, Jizhao Road, Jinnan District, Tianjin 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

天津市环湖医院 

Applicant's institution:

Tianjin Huanhu Hospital 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2020-15 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

天津市环湖医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Tianjin Huanhu Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-03-19 

研究实施负责(组长)单位:

天津市环湖医院 

Primary sponsor:

Tianjin Huanhu Hospital 

研究实施负责(组长)单位地址:

天津市津南区吉兆路6号 

Primary sponsor's address:

No. 6, Jizhao Road, Jinnan District, Tianjin 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

天津

市(区县):

Country:

China

Province:

Tian Jin

City:

单位(医院):

天津市环湖医院

具体地址:

天津市津南区吉兆路6号

Institution
hospital:

Tianjin Huanhu Hospital

Address:

No. 6, Jizhao Road, Jinnan District, Tianjin

经费或物资来源:

自筹 

Source(s) of funding:

self-raised 

研究疾病:

颅脑外伤 

Target disease:

craniocerebral trauma 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional 

研究所处阶段:

I期临床试验 

Study phase:

Phase I 

研究目的:

创伤性脑损伤(traumatic brain injury, TBI)患者可能会出现严重的肺部疾病,如急性呼吸窘迫综合征(acute respiratory distress syndrome, ARDS)和神经源性肺水肿(neurogenic pulmonary edema, NPE) 等。而需要行手术治疗的TBI患者病情重,麻醉和手术时间长,极易发生机械通气相关性肺炎(ventilator associated pneumonia, VAP)等呼吸机相关肺部并发症,进一步加重TBI患者的肺功能障碍,最终导致病死率增加、住院时间延长且神经预后不良等结果。因此,如何改善TBI患者围术期肺功能已成为临床工作中的重点和科研上的热点。 TBI后肺损伤病理机制复杂,主要与交感神经兴奋、炎症介质增加、黏附分子活化、神经递质释放增加以及自主神经系统功能障碍等因素有关,目前尚缺乏有效的临床治疗方案。肺功能障碍在中医属于“喘病”范畴,治疗多从“喘脱”范畴入手,针灸治疗肺部疾病在我国拥有悠久的历史,具有广泛的群众基础。电针(Electroacupuncture,EA)是将传统针刺同现代电技术相结合的产物,刺激强度较普通针刺强,在临床上得到越来越普遍的使用。已有研究表明电针具有肺保护作用,但电针能否减轻颅脑创伤手术患者的肺损伤目前还没有相关研究。探索电针能否作为一种有效的干预措施用于改善颅脑创伤患者围术期肺功能,对于提高麻醉安全,改善患者生存和预后具有重要意义;同时也契合了现今坚持中西医并重,传承发展中医药事业的历史趋势。 

Objectives of Study:

Patients with traumatic brain injury (TBI) may develop severe lung diseases, such as acute respiratory distress syndrome (ARDS) and neurogenic pulmonary edema (NPE). Patients with TBI who require surgical treatment are seriously ill, have long anesthesia and surgery, and are prone to ventilator-associated pneumonia (ventilator associated pneumonia, VAP) and other ventilator-related lung complications, which further aggravate lung dysfunction in TBI patients. Eventually lead to increased mortality, prolonged hospital stay and poor neurological prognosis. Therefore, how to improve the perioperative lung function of TBI patients has become a focus in clinical work and a hot spot in scientific research. The pathological mechanism of lung injury after TBI is complicated, mainly related to factors such as sympathetic nerve excitation, increased inflammatory mediators, activation of adhesion molecules, increased neurotransmitter release, and autonomic nervous system dysfunction. At present, there is still no effective clinical treatment plan. Pulmonary dysfunction belongs to the category of "asthma" in traditional Chinese medicine, and treatment starts from the category of "asthma". Acupuncture has a long history in the treatment of lung diseases in my country and has a broad mass foundation. Electroacupuncture (EA) is a product that combines traditional acupuncture with modern electric technology. The stimulation intensity is stronger than ordinary acupuncture, and it is more and more widely used in clinic. Studies have shown that electro-acupuncture has lung protective effects, but whether electro-acupuncture can reduce lung injury in patients with craniocerebral trauma surgery has not been studied. Exploring whether electroacupuncture can be used as an effective intervention for improving perioperative lung function in patients with craniocerebral trauma is of great significance for improving anesthesia safety, improving patient survival and prognosis; it is also consistent with today's adherence to both Chinese and Western medicine, and inheritance The historical trend of developing Chinese medicine. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

拟在全麻下行颅脑创伤手术的患者,年龄18-65岁,BMI 18-30kg/m2,格拉斯哥昏迷评分在3分到8分之间,ASA分级≦ Ⅲ 级,术前6个月无应用EA或其它针刺相关治疗史,术前无心肺功能不全和严重糖尿病及高血压病史,电针刺激部位无皮肤破损或感染者。 

Inclusion criteria

Patients underwent surgery for craniocerebral trauma under general anesthesia, age 18-65 years old, BMI 18-30kg/m2, Glasgow coma score between 3 and 8, ASA grade ≦ Ⅲ, no application 6 months before surgery EA or other acupuncture-related treatment history, no cardiopulmonary insufficiency, severe diabetes and hypertension history before operation, no skin damage or infection at the site of electroacupuncture stimulation. 

排除标准:

术中出血>800ml,术中MAP<60且不能通过血管活性药物升高者,病人或家属拒绝参加者 

Exclusion criteria:

Intraoperative bleeding >800ml, intraoperative MAP <60 and can not be increased by vasoactive drugs, patients or family members refused to participate 

研究实施时间:

Study execute time:

From2020-08-01To 2020-12-31 

干预措施:

Interventions:

组别:

电针组

样本量:

40

Group:

Electroacupuncture group

Sample size:

干预措施:

电针

干预措施代码:

Intervention:

Electroacupuncture

Intervention code:

组别:

对照组

样本量:

40

Group:

control group

Sample size:

干预措施:

干预措施代码:

Intervention:

none

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tian Jin 

City:

 

单位(医院):

天津市环湖医院 

单位级别:

三甲 

Institution
hospital:

Tianjin Huanhu Hospital  

Level of the institution:

Third Level 1st Class 

测量指标:

Outcomes:

指标中文名:

氧合指数

指标类型:

主要指标 

Outcome:

Oxygenation index

Type:

Primary indicator 

指标中文名:

去甲肾上腺素

指标类型:

次要指标 

Outcome:

NE

Type:

Secondary indicator 

指标中文名:

肾上腺素

指标类型:

次要指标 

Outcome:

E

Type:

Secondary indicator 

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 65 years

随机方法(请说明由何人用什么方法产生随机序列):

设计者通过随机数表法产生

性别:

男女均可

Randomization Procedure (please state who generates the random number sequence and by what method):

The designer generates it through the random number table method

Gender:

Both

盲法:

Blinding:

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

ResMan http://d.medsci.cn

The way of sharing IPD”(include metadata and protocol, If use web-bassed public database, please provide the url):

ResMan http://d.medsci.cn

数据保存和管理(说明:数据包括原始记录、病例记录表等数据,采用什么数据库):

数据包括原始记录和病例记录表,采用ResMan数据库

The repository and management of the data(Please specify what repository will be used for management of the metadata):

Data includes data such as original records and case records, using ResMan database

创建人:

Creater Name:

 2020-06-28
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