经皮穴位电刺激在肺切除术后加速康复中的作用及疗效观察

注册号:

Registration number:

AMCTR-IOR-16000020 

注册号获得时间:

Date of releasing the registration number:

2016/11/14 16:23:34 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

经皮穴位电刺激在肺切除术后加速康复中的作用及疗效观察 

Public title:

Transcutanclus electrical acupoint stimulation in the role of accelerated rehabilitation after pneumonectomy and curative effect observation 

研究课题的正式科学名称:

经皮穴位电刺激在肺切除术后加速康复中的作用及疗效观察 

Scientific title:

Transcutanclus electrical acupoint stimulation in the role of accelerated rehabilitation after pneumonectomy and curative effect observation 

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:

王珂 

研究负责人:

陈彤宇 

Applicant:

Wang Ke 

Study leader:

Chen Tongyu 

申请注册联系人电话:

Applicant telephone:

+86 15921747271 

研究负责人电话:

Study leader's telephone:

+86 13917615016 

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:

wangke8430@163.com 

研究负责人电子邮件:

Study leader's E-mail:

tongchen080@sina.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:

上海张衡路528号 

研究负责人通讯地址:

上海张衡路528号 

Applicant address:

528 Zhangheng Road, Shanghai 

Study leader's address:

528 Zhangheng Road, Shanghai 

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:

上海曙光医院 

Applicant's institution:

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine 

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:

2016-kykt-13 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

上海中医药大学附属曙光医院伦理委员会 

Name of the ethic committee:

IRB of Shuguang Hospital affiliated with Shanghai University of TCM 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-10-26 

研究实施负责(组长)单位:

上海曙光医院 

Primary sponsor:

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

上海张衡路528号 

Primary sponsor's address:

528 Zhangheng Road, Shanghai 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海市

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海曙光医院

具体地址:

上海张衡路528号

Institution
hospital:

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Address:

528 Zhangheng Road, Shanghai

经费或物资来源:

上海申康医院发展中心 

Source(s) of funding:

Shanghai Shenkang Hospital Development Center 

研究疾病:

胸腔镜肺切除手术 

Target disease:

VATS with pneumonectomy 

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:

其它 

Study phase:

Other 

研究目的:

观察经皮穴位电刺激在开胸术后的加速康复中的作用及疗效评价,并作临床推广应用。 

Objectives of Study:

Observation of the role and curative effect evaluation of enhanced recovery with transcutanclus electrical acupoint stimulation after VATS with pneumonectomy, and the promotion of clinical application. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

1.明确诊断为肺脏疾病需手术治疗(包括肺良恶性肿瘤、结核球、肺大疱、肺气肿等),采用术式均为小切口肺切除术,无其他合并症者;2. ASA分级I-II级;3. 年龄18~65岁,男女不限;4. 心、肺、肝、肾及凝血功能能耐受肺部手术要求,既往无免疫系统疾病者;5. 已签署知情同意书者。 

Inclusion criteria

1. A definitive diagnosis for lung disease without other complications which needs surgery(included Lung benign and malignant tumor, tuberculosis, pulmonary bulla, emphysema, etc),and the operations are for small incision pneumonectomy; 2.ASA I-II; 3. Aged 18 to 65 years old; Gender: not limited; 4.Cardiac function, pulmonary function, liver function, renal function and blood coagulation function can tolerate lung surgery requirements, and without immune system disease before; 5. Signing informed consent. 

排除标准:

1.选取的穴位局部有皮肤感染的病人,或相应穴位所属经穴循行经线进行过手术的病人;2.有上肢或者下肢神经损伤的病人;3.近四周内参加过其它临床试验病人;4.不能配合完成研究计划的病人,包括语言困难、传染病及其它病史。 

Exclusion criteria:

1.Local skin infection in selected acupoints or the meridians of selected acupoints with the operation; 2.Upper or lower extremity nerve injury patients; 3.Participating in other clinical trials within four weeks; 4.Who can not cooperate to complete the plan,including dysphasia,infectious disease and other medical history. 

研究实施时间:

Study execute time:

From2016-10-01To 2018-12-31 

干预措施:

Interventions:

组别:

经皮穴位电刺激组

样本量:

68

Group:

TEAS

Sample size:

干预措施:

经皮穴位电刺激

干预措施代码:

TEAS

Intervention:

Transcutanclus Electrical Acupoint Stimulation

Intervention code:

组别:

常规治疗组

样本量:

68

Group:

IA

Sample size:

干预措施:

静脉镇痛

干预措施代码:

IA

Intervention:

Intravenous analgesia

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海曙光医院 

单位级别:

三级甲等医院 

Institution
hospital:

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海浦东医院 

单位级别:

二级甲等医院 

Institution
hospital:

Shanghai Pudong Hospital  

Level of the institution:

Secondary A Hospital 

测量指标:

Outcomes:

指标中文名:

疼痛视觉模拟评分

指标类型:

主要指标 

Outcome:

visual analog scale

Type:

Primary indicator 

指标中文名:

术后恶心呕吐评分

指标类型:

主要指标 

Outcome:

Scale of postoperative nausea and vomiting

Type:

Primary indicator 

指标中文名:

术后排气、排便时间

指标类型:

主要指标 

Outcome:

Time of postoperative exhaust and defecation

Type:

Primary indicator 

指标中文名:

血浆β-内啡肽、亮啡肽和强啡肽浓度的测定

指标类型:

次要指标 

Outcome:

Concentration of serum beta-endorphin, light brown peptide and dyna

Type:

Secondary indicator 

指标中文名:

血浆皮质醇和肾上腺素含量

指标类型:

次要指标 

Outcome:

Content of plasma cortisol and adrenaline

Type:

Secondary indicator 

指标中文名:

不良反应

指标类型:

次要指标 

Outcome:

Adverse reactions

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

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Pending

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):

计算机随机分组

性别:

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

computer-generated random numbers

Gender:

盲法:

分组人员、疗效评估人员和统计人员不参与治疗,治疗医师不参与评估及统计。治疗时,在对照组与经皮穴位电刺激组一致,患者相同穴位均贴有电极片,连接电刺激仪,但不给予通电刺激。

Blinding:

Personnel involved in grouping, efficacy assessment and statistics are not involved in treatment, the physicians do not participate in the assessment and statistics. In the control group, the same acupoints were used as in the TEAS group. The electrodes were also connected but no electronic current was applied.

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:

试验完成后6个月内公开/Within six months after the trial complete

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):

试验完成后6个月公开,在中国临床试验数据管理公共平台上公布。

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

Six months after the trial completed, the data will share at ResMan (clinical trial data management public platform in China).

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):

原始数据保存在上海中医药大学附属曙光医院科研科档案室。

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

Save in the Scientific research department of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine.

创建人:

Creater Name:

 2016-10-10
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