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促胃动力药联合补救性床边盲插提高重症患者螺旋型鼻肠 管幽门后置管成功率的多中心、前瞻性、随机对照临床研究
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注册号:

Registration number:

ChiCTR-INR-16009099 

最近更新日期:

Date of Last Refreshed on:

2018-07-28 

注册时间:

Date of Registration:

2016-08-26 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

促胃动力药联合补救性床边盲插提高重症患者螺旋型鼻肠 管幽门后置管成功率的多中心、前瞻性、随机对照临床研究  

Public title:

Prokinetic agents combined with remedial bedside blind intubation to improve the success rate of post-pyloric placement of spiral nasojejunal tubes in critically ill patients: a multi-center, prospective, randomized-controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

促胃动力药联合补救性床边盲插提高重症患者螺旋型鼻肠 管幽门后置管成功率的多中心、前瞻性、随机对照临床研究  

Scientific title:

Prokinetic agents combined with remedial bedside blind intubation to improve the success rate of post-pyloric placement of spiral nasojejunal tubes in critically ill patients: a multi-center, prospective, randomized-controlled trial 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

胡北 

研究负责人:

陈纯波 

Applicant:

Bei Hu 

Study leader:

Chunbo Chen 

申请注册联系人电话:

Applicant telephone:

+86 15918693156 

研究负责人电话:

Study leader's telephone:

+86 13922745788 

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:

qhubei@hotmail.com 

研究负责人电子邮件:

Study leader's E-mail:

gghicu@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:

广东省广州市中山二路106号 

研究负责人通讯地址:

广东省广州市中山二路106号 

Applicant address:

106 Second Zhongshan Road, Guangzhou, Guangdong, China 

Study leader's address:

106 Second Zhongshan Road, Guangzhou, Guangdong, China 

申请注册联系人邮政编码:

Applicant postcode:

510080 

研究负责人邮政编码:

Study leader's postcode:

510080 

申请人所在单位:

广东省人民医院(广东省医学科学院) 

Applicant's institution:

Guangdong General Hospital, Guangdong Academy of Medical Sciences  

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:

NO. GDREC2016182H(R1) 

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:

广东省人民医院(广东省医学科学院)医学研究伦理委员会  

Name of the ethic committee:

Research Ethics Committee Guangdong General hospital, Guangdong Academy of Medical Sciences  

伦理委员会批准日期:

Date of approved by ethic committee:

2016-07-27 

伦理委员会联系人:

陈向阳 

Contact Name of the ethic committee:

Chen Xiangyang 

伦理委员会联系地址:

广东省广州市中山二路106号 

Contact Address of the ethic committee:

106 Second Zhongshan Road, Guangzhou, Guangdong, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

广东省人民医院(广东省医学科学院) 

Primary sponsor:

Guangdong General hospital, Guangdong Academy of Medical Sciences  

研究实施负责(组长)单位地址:

广东省广州市中山二路106号 

Primary sponsor's address:

106 Second Zhongshan Road, Guangzhou, Guangdong, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广东省人民医院(广东省医学科学院)

具体地址:

广东省广州市中山二路106号

Institution
hospital:

Guangdong General hospital, Guangdong Academy of Medical Sciences

Address:

106 Second Zhongshan Road, Guangzhou, Guangdong, China

经费或物资来源:

广东现代医院管理研究所基金 

Source(s) of funding:

Guangdong Institute of modern hospital management fund  

研究疾病:

螺旋型鼻肠管置管 

Target disease:

self-propelled feeding tubes insertion 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

本项目拟进行一项多中心、前瞻性、随机对照研究,探讨重症患者放置螺旋型鼻肠管后常规应用促胃动力药结合补救性盲插(单导丝法)置管的有效性和安全性。 

Objectives of Study:

This aim of this prospective, multicenter, randomized controlled clinical trial was to investigate the effectiveness and safety of prokinetic agents combined with remedial bedside blind intubation in promoting the success rate of post-pyloric placement of spiral nasojejunal tube.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

⑴年龄≥18 岁; ⑵入住 ICU; ⑶需行肠内营养支持 3 天以上者; ⑷胃残留量增加(单次测量>150ml 或 12 小时累积量>500ml); ⑸已签署知情同意书。  

Inclusion criteria

1. aged older than 18 years; 2. admitted to ICU; 3. requiring enteral nutrition support for more than 3 days; 4. gastric residual volume increased (single measurement > 150ml or cumulative volume in 12 hours > 500ml); 5. informed consent has been signed. 

排除标准:

⑴有行经皮胃造瘘或空肠造瘘指征者; ⑵食道静脉曲张或狭窄,或曾行较大胃食管手术如食管切除或胃切除者; ⑶活动性上消化道出血; ⑷严重鼻咽部损伤或狭窄; ⑸严重凝血功能障碍; ⑹胃恶性肿瘤、消化性溃疡或机械性肠梗阻; ⑺孕妇; ⑻禁忌使用胃复安及多潘立酮者; ⑼对泛影葡胺过敏者。 

Exclusion criteria:

1. Indications of percutaneous gastrostomy or jejunostomy; 2. esophageal varices or strictures, or previous major gastro-esophageal surgery (for example; 3. activity of the upper digestive tract hemorrhage; 4. serious injury or stenosis of nasopharynx; 5. severe coagulation disorder; 6. malignant tumor, peptic ulcer of the stomach or intestinal mechanical obstruction; 7. pregnant; 8. contraindication of domperidone and metoclopramide; 9. history of allergy to meglumine diatrizoate. 

研究实施时间:

Study execute time:

From2016-09-01To  

征募观察对象时间:

Recruiting time:

From2016-09-01To  

干预措施:

Interventions:

组别:

促胃动力药联合补救法组

样本量:

130

Group:

Prokinetic agents combined with remedial bedside blind intubation group

Sample size:

干预措施:

应用促胃动力药联合手法补救性置管

干预措施代码:

Intervention:

Prokinetic agents combined with remedial bedside blind intubation

Intervention code:

组别:

促胃动力药组

样本量:

130

Group:

Prokinetic agents group

Sample size:

干预措施:

促胃动力药(甲氧氯普胺或多潘立酮)

干预措施代码:

Intervention:

Prokinetic agents (metoclopramide hydrochloride injection or domperidone suspension)

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东省 

市(区县):

广州市 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

广东省人民医院(广东省医学科学院) 

单位级别:

三级甲等 

Institution
hospital:

Guangdong General hospital, Guangdong Academy of Medical Sciences  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东省 

市(区县):

广州市 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

广州市第一人民医院 

单位级别:

三级甲等 

Institution
hospital:

Guangzhou First People's Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东省 

市(区县):

中山市 

Country:

China 

Province:

Guangdong 

City:

Zhongshan 

单位(医院):

广东省中山市小榄人民医院 

单位级别:

三级甲等 

Institution
hospital:

Zhongshan xiaolan People's Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

新疆维吾尔自治区 

市(区县):

喀什 

Country:

China 

Province:

Xinjiang Uygur Autonomous Region 

City:

kashgar 

单位(医院):

新疆喀什地区第一人民医院 

单位级别:

三级甲等 

Institution
hospital:

Xinjiang Kashgar First People's Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

螺旋型鼻肠管幽门后置管成功率

指标类型:

主要指标 

Outcome:

success rate of post-pyloric placement of spiral nasaljejunal tubes

Type:

Primary indicator 

测量时间点:

置管后24小时

测量方法:

X线摄片

Measure time point of outcome:

24 hour after tube insertion

Measure method:

X ray

指标中文名:

置管所用时间

指标类型:

次要指标 

Outcome:

time for tube insertion

Type:

Secondary indicator 

测量时间点:

置管结束

测量方法:

计时

Measure time point of outcome:

after tube placement

Measure method:

timing

指标中文名:

尝试次数

指标类型:

次要指标 

Outcome:

attempts

Type:

Secondary indicator 

测量时间点:

置管结束

测量方法:

计数

Measure time point of outcome:

after tube placement

Measure method:

counting

指标中文名:

不良事件

指标类型:

副作用指标 

Outcome:

adverse events

Type:

Adverse events 

测量时间点:

研究过程中

测量方法:

观察并记录

Measure time point of outcome:

during the study

Measure method:

observe and record

指标中文名:

决策置管-开始肠内营养时间

指标类型:

次要指标 

Outcome:

time between decision of tube placement and the beginning of enteral nutrition

Type:

Secondary indicator 

测量时间点:

开始肠内营养

测量方法:

计时

Measure time point of outcome:

at the beginning of enteral nutrition

Measure method:

timing

指标中文名:

置管相关 X 线摄片次数

指标类型:

次要指标 

Outcome:

X rays related to tube placement

Type:

Secondary indicator 

测量时间点:

置管结束

测量方法:

计数

Measure time point of outcome:

after tube placement

Measure method:

counting

指标中文名:

置管相关费用

指标类型:

次要指标 

Outcome:

cost related to tube placement

Type:

Secondary indicator 

测量时间点:

置管结束

测量方法:

计数

Measure time point of outcome:

after tube placement

Measure method:

counting

采集人体标本:

Collecting sample(s)
from participants:

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 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

专业统计人员通过计算机产生随机序列

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

Random sequences aregenerated from computer by professional statisticians

盲法:

Not stated

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

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):

原始数据于实验结束6个月以内采用临床试验公共管理平台向公众开放查询

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

The raw data will open to the public with public management platform in the 6 months after clinical trials finished

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

原始数据采用临床试验公共管理平台进行记录和管理

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

The raw data will record and manag by the public management platform of clinical trials

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-08-26
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