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Improved Biomass and Ventilation for Cooking Impact on Lung Function and Incidence of Chronic Obstructive Pulmonary Disease: A 9-year prospective cohort study in rural Southern China

注册号:

Registration number:

ChiCTR-OCH-12002398 

注册号获得时间:

Date of releasing the registration number:

2012/08/08 

注册号状态:

补注册 

Registration Status:

Retrospective registration 

注册题目:

改善生物燃料使用和厨房通风对肺功能和COPD的影响 

Public title:

Improved Biomass and Ventilation for Cooking Impact on Lung Function and Incidence of Chronic Obstructive Pulmonary Disease: A 9-year prospective cohort study in rural Southern China 

研究课题的正式科学名称:

COPD 早期筛查、人群综合干预研究 

Scientific title:

The Study on Prevalence and Comprehensive Intervention of COPD in China 

研究课题代号(代码):

Study subject ID:

2001BA703B03(A) (P.R.) and 2012BAI05B01 (P.R.) 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

周玉民 

研究负责人:

冉丕鑫 

Applicant:

Yumin Zhou 

Study leader:

Pixin Ran 

申请注册联系人电话:

Applicant telephone:

+86 13059177467 

研究负责人电话:

Study leader's telephone:

+86 13922765811 

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:

zhouyumin410@126.com 

研究负责人电子邮件:

Study leader's E-mail:

pxran@gzhmc.edu.cn 

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:

广州市沿江西路151号 

研究负责人通讯地址:

广州市东风西路195号 

Applicant address:

No.151, West Yanjiang Road, Guangzhou, China 

Study leader's address:

No.195, West Dongfeng Road, Guangzhou 

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:

广州医学院 

Applicant's institution:

Guangzhou Medical 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:

2002医审第(3)号 

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:

广州呼吸疾病研究所医学伦理委员会 

Name of the ethic committee:

Ethics Committee of Guangzhou Institute of Respiratory Diseases 

伦理委员会批准日期:

Date of approved by ethic committee:

2002/05/20 

研究实施负责(组长)单位:

广州呼吸疾病研究所 

Primary sponsor:

Guangzhou Institute of Respiratory Diseases 

研究实施负责(组长)单位地址:

广州市沿江西路151号 

Primary sponsor's address:

No.151, West Yanjiang Road, Guangzhou, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

省(直辖市):

市(区县):

Country:

Province:

City:

单位(医院):

国家科技部

具体地址:

Institution
hospital:

The Ministry of Science and Technology

Address:

经费或物资来源:

国家科技部科技支撑项目2001BA703B03(A) (P.R.) and 2012BAI05B01 (P.R.). 

Source(s) of funding:

The National Key Technology R&D Program 2001BA703B03(A) (P.R.) and 2012BAI05B01 (P.R.). 

研究疾病:

慢性阻塞性肺疾病 

Target disease:

Chronic Obstructive Pulmonary Disease 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational 

研究所处阶段:

其它 

Study phase:

Other 

研究目的:

评价改善生物燃料使用和厨房通风对肺功能和COPD的影响 

Objectives of Study:

To assess longitudinal effect of improved biomass and ventilation for cooking on pulmonary function and COPD 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

1.40岁以上男性或女性居民 2.完成了COPD基线调查 3.基线采用生物燃料烹饪且厨房通风条件差 4.签署了知情同意书同意参加该队列研究 

Inclusion criteria

1.male or female residents at the age of 40 years or older; 2.completed acceptable baseline surveys; 3.cooked with biomass and poor ventilation; 4.gave written informed consent to participate in this cohort study. 

排除标准:

1.诊断有活动性肺结核、哮喘、明显的支气管扩张、肺囊性纤维化、间质性肺疾病、肺栓塞、恶性肿瘤、肺切除手术或严重的其他系统疾病或影响肺功能测试的症状 2.以及计划长时间外出者 3.无法联系、外出、死亡、拒绝、依从性差及其他不能完成研究的原因 

Exclusion criteria:

1.a diagnosis with active tuberculosis, asthma or obvious bronchiectasis, cystic fibrosis, interstitial lung disease, or pulmonary thromboembolic disease, malignant tumor, history of thoracotomy with pulmonary resection, or uncontrolled or serious diseases or other symptoms that could potentially affect the spirometry test; 2.a plan to move out permanently; 3.failure to contact, migration,death, refusal to proceed, or poor compliance, or other any reason that affect the study completion. 

研究实施时间:

Study execute time:

From2002-11-1To 2011-11-30 

干预措施:

Interventions:

组别:

清洁燃料使用组

样本量:

433

Group:

Clean fuels group

Sample size:

干预措施:

卫生宣教和改善烹饪燃料及厨房通风

干预措施代码:

Intervention:

health education and improving on cooking fuels and kitchen ventilation

Intervention code:

组别:

通风改善组

样本量:

376

Group:

Improved ventilation group

Sample size:

干预措施:

卫生宣教和改善烹饪燃料及厨房通风

干预措施代码:

Intervention:

health education and improving on cooking fuels and kitchen ventilation

Intervention code:

组别:

既使用清洁燃料又改善厨房通风组

样本量:

287

Group:

both Improved ventilation and clean Fuels group

Sample size:

干预措施:

卫生宣教和改善烹饪燃料及厨房通风

干预措施代码:

Intervention:

health education and improving on cooking fuels and kitchen ventilation

Intervention code:

组别:

使用清洁燃料或改善厨房通风之一组

样本量:

235

Group:

either improved ventilation or clean Fuels group

Sample size:

干预措施:

卫生宣教和改善烹饪燃料及厨房通风

干预措施代码:

Intervention:

health education and improving on cooking fuels and kitchen ventilation

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

指标中文名:

肺功能9年的下降量

Outcome:

9-year declines in lung function

指标中文名:

COPD新发病率

Outcome:

incidence rate of COPD

指标中文名:

室内空气污染物

Outcome:

indoor air pollutants

采集人体标本:

Collecting sample(s)
from participants:

未填写任何采集标本。

No sample added。

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 40 years
最大 Max age 81 years

随机方法(请说明由何人用什么方法产生随机序列):

非随机方法

性别:

男女均可

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

non-Randomization

Gender:

Both

盲法:

Blinding:

研究负责(组长)单位:

Organizer institution (leader institution):

资料收集汇总单位:

Data collection Institution:

资料管理单位:

Data management Institution:

资料分析单位:

Data analysis Institution:

创建人:

Creater Name:

zhouyumin 2012/7/31 23:21:56
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