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肺保护性通气策略中吸入氧浓度对术后肺部并发症影响的临床研究
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注册号:

Registration number:

ChiCTR1800014901 

最近更新日期:

Date of Last Refreshed on:

2019-06-11 

注册时间:

Date of Registration:

2018-02-13 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

肺保护性通气策略中吸入氧浓度对术后肺部并发症影响的临床研究 

Public title:

Effect of Protective ventilation with a high versus low inspiratory oxygen fraction on postoperative pulmonary complications 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

肺保护性通气策略中吸入氧浓度对术后肺部并发症影响的单中心、前瞻性、随机、对照的临床研究 

Scientific title:

Effect of protective ventilation with a high versus low inspiratory oxygen fraction on postoperative pulmonary complications:single-center,prospective,randomized and 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:

李雪霏 

研究负责人:

余海 

Applicant:

Xuefei Li 

Study leader:

Hai Yu 

申请注册联系人电话:

Applicant telephone:

+86 18280081064 

研究负责人电话:

Study leader's telephone:

+86 18980601548 

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:

kikyou015@163.com 

研究负责人电子邮件:

Study leader's E-mail:

706603748@qq.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:

中国四川省成都市武侯区国学巷37号 

研究负责人通讯地址:

中国四川省成都市武侯区国学巷37号 

Applicant address:

37 Guo Xue Xiang, Chengdu, Sichuan, China 

Study leader's address:

37 Guo Xue Xiang, Chengdu, Sichuan, China 

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:

四川大学华西医院 

Applicant's institution:

West China Hospital, Sichuan University 

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:

2018-18 

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:

四川大学华西医院临床试验与生物医学伦理专委会 

Name of the ethic committee:

The Medical Research Ethical Committee of the West China Hospital of Sichuan University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-02-07 

伦理委员会联系人:

左泽锦 

Contact Name of the ethic committee:

Zhejin Zuo 

伦理委员会联系地址:

中国四川省成都市武侯区国学巷37号 

Contact Address of the ethic committee:

37 Guo Xue Xiang, Chengdu, Sichuan, 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:

四川大学华西医院 

Primary sponsor:

West China Hospital,Sichuan University 

研究实施负责(组长)单位地址:

中国四川省成都市武侯区国学巷37号 

Primary sponsor's address:

37 Guo Xue Xiang, Chengdu, Sichuan, 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):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

四川大学华西医院

具体地址:

中国四川省成都市武侯区国学巷37号

Institution
hospital:

West China Hospital,Sichuan University

Address:

37 Guo Xue Xiang, Chengdu, Sichuan, China

经费或物资来源:

横向课题经费 

Source(s) of funding:

The lateral research funds 

研究疾病:

术后肺部并发症 

Target disease:

postoperative pulmonary complications 

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:

其它 

Study phase:

N/A 

研究目的:

评估肺保护性通气策略中吸入氧浓度对腹部手术患者术后肺部并发症的影响 

Objectives of Study:

To compare the effect of protective ventilation with a high versus low inspiratory oxygen fraction on postoperative pulmonary complications. 

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:

1.年龄≥18岁 2.ASA:I-III级 3.预计手术时间≥2小时 4.全麻插管,预计将进行拔管的择期腹部手术 5.签署知情同意书。 

Inclusion criteria

1. Age≥18 years; 2. ASA classification 2-3; 3. Planned abdominal surgery> 2 hours; 4. Undergoing abdominal surgery and general anaesthesia expected to be extubated; 5. Written inform consent. 

排除标准:

1.任何原因不能配合研究或研究者认为不宜纳入本试验 2.术前3月内急性肺损伤或急性呼吸窘迫综合征病史 3.合并严重心、脑、肺、肝、肾疾病者 4.BMI>30Kg/m2 5.孕期、哺乳期女性 6.需要再次手术或者术后需要通气、循环支持者 7.已参与其他临床试验  

Exclusion criteria:

1. Refused to cooperate or be inappropriate; 2. Acute lung injury or acute respiratory distress syndrome in last three months; 3. Having serious heart,brain,lung,liver or kidney illness; 4. BMI >30Kg/m2; 5. Pregnant or breast-feeding; 6. Requiring re-operation or postoperative ventilation/circulation supports; 7. Participation in another experimental protocol at the time of intervention selection. 

研究实施时间:

Study execute time:

From2018-03-01To 2019-03-01 

干预措施:

Interventions:

组别:

低氧组

样本量:

126

Group:

Low FiO2 group

Sample size:

干预措施:

术中吸入氧浓度为0.3

干预措施代码:

Intervention:

0.3 FiO2

Intervention code:

组别:

高氧组

样本量:

126

Group:

High FiO2 group

Sample size:

干预措施:

术中吸入氧浓度为0.8

干预措施代码:

Intervention:

0.8 FiO2

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

四川大学华西医院 

单位级别:

三级甲等 

Institution
hospital:

West China Hospital,Sichuan University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

术后肺部并发症包括呼吸衰竭、肺部感染、胸腔积液、肺不张、气胸、支气管痉挛、吸入性肺炎、肺栓塞

指标类型:

主要指标 

Outcome:

Postoperative pulmonary complications, include respiratory failure, respiratory infection, pleural effusion, atelectasis, pneumothorax, bronchospasm, aspiration pneumonitis, pulmonary embolism

Type:

Primary indicator 

测量时间点:

术后7天及30天

测量方法:

Measure time point of outcome:

7 days and 30 days after surgery

Measure method:

指标中文名:

手术切口感染

指标类型:

次要指标 

Outcome:

Surgical site infection

Type:

Secondary indicator 

测量时间点:

术后7天

测量方法:

Measure time point of outcome:

7 days after surgery

Measure method:

指标中文名:

术后恶心呕吐

指标类型:

次要指标 

Outcome:

Postoperative nausea and vomiting

Type:

Secondary indicator 

测量时间点:

术后7天

测量方法:

Measure time point of outcome:

7 days after surgery

Measure method:

指标中文名:

术后全因死亡率

指标类型:

次要指标 

Outcome:

Postoperative mortality

Type:

Secondary indicator 

测量时间点:

术后7天及30天

测量方法:

Measure time point of outcome:

7 days and 30 days after surgery

Measure method:

指标中文名:

术后脓毒症

指标类型:

次要指标 

Outcome:

Postoperative sepsis

Type:

Secondary indicator 

测量时间点:

术后30天

测量方法:

Measure time point of outcome:

30 days after surgery

Measure method:

指标中文名:

术后感染性休克

指标类型:

次要指标 

Outcome:

Postoperative septic shock

Type:

Secondary indicator 

测量时间点:

术后30天

测量方法:

Measure time point of outcome:

30 days after surgery

Measure method:

指标中文名:

术后心肌缺血

指标类型:

次要指标 

Outcome:

Postoperative myocardial ischemia

Type:

Secondary indicator 

测量时间点:

术后30天

测量方法:

Measure time point of outcome:

30 days after surgery

Measure method:

指标中文名:

术后心力衰竭

指标类型:

次要指标 

Outcome:

Postoperative heart failure

Type:

Secondary indicator 

测量时间点:

术后30天

测量方法:

Measure time point of outcome:

30 days after surgery

Measure method:

指标中文名:

术后急性肾损伤

指标类型:

次要指标 

Outcome:

Postoperative acute kidney injury

Type:

Secondary indicator 

测量时间点:

术后30天

测量方法:

Measure time point of outcome:

30 days after surgery

Measure method:

指标中文名:

术后泌尿系统感染

指标类型:

次要指标 

Outcome:

Postoperative urinary system infection

Type:

Secondary indicator 

测量时间点:

术后30天

测量方法:

Measure time point of outcome:

30 days after surgery

Measure method:

指标中文名:

术后吻合口瘘

指标类型:

次要指标 

Outcome:

Postoperative anastomotic fistula

Type:

Secondary indicator 

测量时间点:

术后30天

测量方法:

Measure time point of outcome:

30 days after surgery

Measure method:

指标中文名:

再插管

指标类型:

次要指标 

Outcome:

Postoperative reintubation

Type:

Secondary indicator 

测量时间点:

术后30天

测量方法:

Measure time point of outcome:

30 days after surgery

Measure method:

指标中文名:

非计划转入ICU

指标类型:

次要指标 

Outcome:

Postoperative non-planed transferred to ICU

Type:

Secondary indicator 

测量时间点:

术后30天

测量方法:

Measure time point of outcome:

30 days after surgery

Measure method:

指标中文名:

住院时间

指标类型:

次要指标 

Outcome:

Length of Hospital Stay

Type:

Secondary indicator 

测量时间点:

From the day of surgery up to Hospital discharge, maximum censoring at day 30 after surgery

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺部并发症分级

指标类型:

次要指标 

Outcome:

the severity grade of postoperative pulmonary complications

Type:

Secondary indicator 

测量时间点:

术后7天和30天

测量方法:

Measure time point of outcome:

Day 7, day 30 post surgery

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

none

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 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):

由特定的研究员使用统计软件SPSS 22.0产生计算机随机序列对受试患者进行1:1的随机分组。

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

All patients were assigned in a 1:1 ratio to one of the two groups, according to computer-generated randomization codes (SPSS 22.0) by a specific researcher.

盲法:

受试者、外科团队、麻醉复苏室及病房的医生、护士、研究者不知道分组情况。负责受试者的主管麻醉医生知道分组情况。

Blinding:

The patient,surgical team,doctors and nurses in PACU and ward,all participating researchers were blinded to treatment assignment.The anaesthetist responsible for the patient know the allocation.

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:

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):

临床试验公共管理平台.http://www.medresman.org/uc/index.aspx

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

Research Manager.http://www.medresman.org/uc/index.aspx

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:

采用病历记录表采集数据,临床试验公共管理平台(ResMan)管理数据。

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

Case record form to collect data; ResMan to manage data.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-02-13
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