今天是:2022-08-12 星期五

【辑】两种不同方法滴定个体化PEEP对肥胖患者术后肺不张的影响
下载XML文档

注册号:

Registration number:

ChiCTR2000039144 

最近更新日期:

Date of Last Refreshed on:

2021-01-16 

注册时间:

Date of Registration:

2020-10-19 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

【辑】两种不同方法滴定个体化PEEP对肥胖患者术后肺不张的影响 

Public title:

Two different ways of individualized PEEP titration and their impact on postoperative atelectasis of obese patients 

注册题目简写:

iPEEP对肥胖患者肺不张的影响 

English Acronym:

Effect of iPEEP on atelectasis in obese patients 

研究课题的正式科学名称:

两种不同方法滴定个体化PEEP对肥胖患者术后肺不张的影响 

Scientific title:

Two different ways of individualized PEEP titration and their impact on postoperative atelectasis of obese patients 

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:

王清原 

研究负责人:

安立新 

Applicant:

Qingyuan Wang 

Study leader:

Lixin An 

申请注册联系人电话:

Applicant telephone:

+86 15652284820 

研究负责人电话:

Study leader's telephone:

+86 15652284820 

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:

2503084127@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

anlixin8120@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:

北京市西城区永安路95号 

研究负责人通讯地址:

北京市西城区永安路95号 

Applicant address:

95 Yong'an Road, Xicheng District, Beijing, China 

Study leader's address:

95 Yong'an Road, Xicheng District, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

100050 

研究负责人邮政编码:

Study leader's postcode:

100050 

申请人所在单位:

首都医科大学附属北京友谊医院 

Applicant's institution:

Beijing Friendship Hospital Affiliated to Capital 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:

2020-P2-145-01 

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:

首都医科大学附属北京友谊医院生命伦理委员会 

Name of the ethic committee:

Life ethics committee of Beijing Friendship Hospital affiliated to Capital Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-08-04 

伦理委员会联系人:

李悦 

Contact Name of the ethic committee:

Li Yue 

伦理委员会联系地址:

北京市西城区永安路95号北京友谊医院体检中心302 

Contact Address of the ethic committee:

302 Beijing Friendship Hospital Medical Examination Center, 95 Yong'an Road, Xicheng District, Beijing, 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:

首都医科大学附属北京友谊医院 

Primary sponsor:

Beijing Friendship Hospital affiliated to Capital Medical University 

研究实施负责(组长)单位地址:

北京市西城区永安路95号 

Primary sponsor's address:

95 Yong'an Road, Xicheng District, Beijing, 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):

北京

市(区县):

北京

Country:

China

Province:

Beijing

City:

Beijing

单位(医院):

北京友谊医院

具体地址:

永安路95号

Institution
hospital:

Beijing Friendship Hospital

Address:

95 Yong'an Road, Xicheng District, Beijing, China

经费或物资来源:

无 

Source(s) of funding:

None 

研究疾病:

术后肺不张 

Target disease:

Postoperative atelectasis 

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:

I期临床试验 

Study phase:

研究目的:

以最佳Cstat的方法与利用电阻抗肺断层扫描检测滴定最佳个体化PEEP,观察其对肥胖患者在腹腔镜手术术中氧合和肺不张的影响;通过卫生学指标(住院时间、住院花费)等进一步证实个体化PEEP对减少肥胖患者术后肺部并发症和加速术后康复的意义,进而验证最佳Cstat的方法滴定个体化PEEP的有效性。 

Objectives of Study:

This study is going to exploit the use of optimal static lung compliance and electrical impedence tomography in individualized PEEP titration to observe their impact on intraoperative oxygenation and atelectasis in obese patients receiving laparoscopic surgery, further explore individualized PEEP's influence on reduction of postoperative pulmonary complications and on acceleration of postoperative recovery through clinical index (length of stay in hospital, hospital expenses etc.), and hence to confirm the effectiveness of titrating individualized PEEP according to optimal static lung compliance. 

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:

BMI >=32.5; 择期在全身麻醉、腹腔镜下行减重代谢手术的患者; 年龄18~60岁; 术后肺部并发症评分为中等或高等风险; ASA分级I-III级; 签署知情同意书 

Inclusion criteria

1. Patients with BMI > 32.5; 2. Patients scheduled for weight loss and metabolic surgery under general anesthesia and laparoscopy; 3. Patients aged 18-60 years old; 4. Patients with moderate or high risk of postoperative pulmonary complications; 5. ASA I-III patients; 6. Patients who signed informed consent. 

排除标准:

年龄<18岁或>60岁的患者; ASA分级>或=IV级; 有严重的慢性阻塞性肺病(COPD,GOLD分级III-IV级); 有严重的或者不能控制的支气管哮喘的病史; 合并肺转移瘤的病人; 外科手术前正在进行肾替代治疗; 充血性心力衰竭(NYHA分级III-IV级); 术后不能及时拔管,需要带管回ICU的患者。 

Exclusion criteria:

1. Patients aged < 18 or > 60; 2. Patients with ASA grade > or = IV; 3. Patients with severe chronic obstructive pulmonary disease (COPD, gold grade III-IV); 4. Patients with a history of severe or uncontrollable bronchial asthma; 5. Patients with pulmonary metastases; 6. Patients undergoing renal replacement therapy before surgery; 7. Patients with congestive heart failure (NYHA grade III-IV); 8. Patients who can't extubate in time after operation and need to take the tube back to ICU. 

研究实施时间:

Study execute time:

From2020-11-15To 2022-09-01 

征募观察对象时间:

Recruiting time:

From2020-11-15To 2022-09-17 

干预措施:

Interventions:

组别:

最佳Cstat滴定iPEEP

样本量:

70

Group:

Optimal Cstat titrating iPEEP

Sample size:

干预措施:

用最佳静态肺顺应性法滴定的个体化PEEP进行术中机械通气

干预措施代码:

C

Intervention:

Use optimal static lung compliance directed individualized PEEP titration to choose the ideal PEEP for each patient.And ventilate patients intraoperatively with the ideal PEEP.

Intervention code:

组别:

EIT法滴定iPEEP

样本量:

70

Group:

EIT titrating iPEEP

Sample size:

干预措施:

用电阻抗肺断层扫描成像法滴定个体化PEEP进行术中通气

干预措施代码:

E

Intervention:

Use electrical impedance tomography guided individualized PEEP titration to choose the ideal PEEP for each patient.And ventilate patients intraoperatively with the ideal PEEP.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

北京 

Country:

China 

Province:

Beijing 

City:

Beijing 

单位(医院):

北京友谊医院 

单位级别:

三甲医院 

Institution
hospital:

Beijing Friendship Hospital  

Level of the institution:

Grade 3A 

测量指标:

Outcomes:

指标中文名:

氧合指数

指标类型:

次要指标 

Outcome:

the ratio of arterial oxygenation partial pressure to inspiratory oxygen fractionto

Type:

Secondary indicator 

测量时间点:

气管插管后,最后一次肺复张后,气管拔管前

测量方法:

血气分析

Measure time point of outcome:

after intubation, after the last recruitment manoeuvre

Measure method:

blood gas analysis

指标中文名:

呼吸参数

指标类型:

次要指标 

Outcome:

ventilation parameters

Type:

Secondary indicator 

测量时间点:

术中

测量方法:

呼吸机测量

Measure time point of outcome:

during surgery

Measure method:

use the mechanical ventilator to measure

指标中文名:

术后肺部并发症

指标类型:

次要指标 

Outcome:

postoperative pulmonary complications

Type:

Secondary indicator 

测量时间点:

术后随访直至出院

测量方法:

依据指南确定

Measure time point of outcome:

during follow up until hospital discharge

Measure method:

define by clinical guidelines

指标中文名:

卫生经济学指标

指标类型:

次要指标 

Outcome:

health economics indicators

Type:

Secondary indicator 

测量时间点:

术后随访直至出院

测量方法:

Measure time point of outcome:

during follow up until hospital discharge

Measure method:

指标中文名:

血流动力学参数

指标类型:

次要指标 

Outcome:

hemodynamic parameter

Type:

Secondary indicator 

测量时间点:

术中

测量方法:

Measure time point of outcome:

during surgery

Measure method:

指标中文名:

血气分析参数

指标类型:

次要指标 

Outcome:

blood gas parameters

Type:

Secondary indicator 

测量时间点:

术前,插管后,iPEEP滴定后,拔管前,拔管后

测量方法:

Measure time point of outcome:

preoperation, after intubation, after individualized PEEP titration, before extubation, after extubation i

Measure method:

指标中文名:

麻醉药用量

指标类型:

次要指标 

Outcome:

anesthesia medicine dosage

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

麻醉恢复时间

指标类型:

次要指标 

Outcome:

recovery time of anesthesia

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺塌陷面积比例

指标类型:

主要指标 

Outcome:

percent mass of collapsed lung tissue

Type:

Primary indicator 

测量时间点:

术后即刻和术后2h

测量方法:

电阻抗肺断层扫描成像法

Measure time point of outcome:

immediately after surgery and two hours after surgery

Measure method:

electrical impedance tomography

指标中文名:

血清降钙素原

指标类型:

次要指标 

Outcome:

PCT

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

白介素-6

指标类型:

次要指标 

Outcome:

IL-6

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 60 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):

按病例数制作相应数量的信封,按中央随机系统静态随机算法,每个信封内装有一个随机编码,患者按病例号序列进入试验,研究者在决定患者进入本临床试验后才能随机打开信封,根据信封中指定的随机编码入组。按照1:1的比例进入两组:一组是最佳Cstat方法滴定iPEEP组(C组),n=70例;一组是EIT滴定iPEEP组(E组),n=70例。

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

Participants will be randomized to the CG(static lung compliance directed individualized PEEP titration group)or EG(electrical impedance tomography guided individualized PEEP titration group)groups in a ratio of 1:1. Randomization will be carried out by static randomization with the Interactive Voice Response System.

盲法:

单盲,本研究患者盲,研究者不盲。

Blinding:

Single blind, the patients in this study are blind, and the researchers are not blind.

是否共享原始数据:

IPD sharing

是Yes

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):

实验结束,文章发表后,联系负责人。

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

After the trial is complete and the thesis is published, contact the study leader for sharing of IPD.

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:

病例记录表(CRF)

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

Case Record Form

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2020-10-19
返回列表