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Effect of driving pressure-guided mechanical ventilation on brain relaxation and blood loss during craniotomy: a randomized controlled noninferiority trial
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注册号:

Registration number:

ChiCTR2200055936 

最近更新日期:

Date of Last Refreshed on:

2022-01-31 

注册时间:

Date of Registration:

2022-01-26 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

以驱动压为指导的通气模式对择期开颅手术脑松弛及出血量的影响:一项随机、对照、非劣效试验 

Public title:

Effect of driving pressure-guided mechanical ventilation on brain relaxation and blood loss during craniotomy: a randomized controlled noninferiority trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

以驱动压为指导的通气模式对择期开颅手术脑松弛及出血量的影响:一项随机、对照、非劣效试验 

Scientific title:

Effect of driving pressure-guided mechanical ventilation on brain relaxation and blood loss during craniotomy: a randomized controlled noninferiority 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:

彭科 

研究负责人:

嵇富海 

Applicant:

Ke Peng 

Study leader:

Fu-hai Ji 

申请注册联系人电话:

Applicant telephone:

15962155989 

研究负责人电话:

Study leader's telephone:

13656207331 

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:

pengke0422@163.com 

研究负责人电子邮件:

Study leader's E-mail:

jifuhai@suda.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:

苏州市姑苏区十梓街188号 

研究负责人通讯地址:

苏州市姑苏区十梓街188号 

Applicant address:

188 Shizi Street, Suzhou, Jiangsu, China 

Study leader's address:

188 Shizi Street, Suzhou, Jiangsu, 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:

苏州大学附属第一医院 

Applicant's institution:

The First Affiliated Hospital of Suzhou 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:

(2021)伦审批第279号 

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:

苏州大学附属第一医院医学伦理委员会 

Name of the ethic committee:

Ethics Committee of the First Affiliated Hospital of Suzhou University 

伦理委员会批准日期:

Date of approved by ethic committee:

2021-12-01 

伦理委员会联系人:

吴霜杰 

Contact Name of the ethic committee:

Shuangjie Wu 

伦理委员会联系地址:

中国江苏省苏州市平海路899号 

Contact Address of the ethic committee:

899 Pinghai Road, Suzhou, Jiangsu, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

0512-67780655 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

sdfyec@126.com 

研究实施负责(组长)单位:

苏州大学附属第一医院 

Primary sponsor:

First Affiliated Hospital of Soochow University 

研究实施负责(组长)单位地址:

苏州市姑苏区十梓街188号 

Primary sponsor's address:

188 Shizi Street, Suzhou, Jiangsu, 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):

江苏

市(区县):

苏州

Country:

China

Province:

Jiangsu

City:

Suzhou

单位(医院):

苏大附一院

具体地址:

苏州市姑苏区十梓街188号

Institution
hospital:

First Affiliated Hospital of Soochow University

Address:

188 Shizi Street, Gusu District

经费或物资来源:

研究者自筹 

Source(s) of funding:

Self-funded 

研究疾病:

开颅手术时的通气模式 

Target disease:

mechanical ventilation during craniotomy 

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:

观察以驱动压为指导的通气策略与常规容量控制通气策略相比,对颅脑手术患者术中出血量及术野暴露是否存在不良影响,为颅脑手术的通气策略提供一定参考意义。 

Objectives of Study:

To assess the effects of driving pressure-guided mechanical ventilation vs. conventional volume controlled ventilation on brain relaxation and intraoperative blood loss in paitents undergoing craniotomy. 

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:

年龄≥18周岁,性别不限; ASA分级I~Ⅲ级;全身麻醉的择期颅脑手术患者;体重指数BMI 18-30kg/m2;清楚了解实验过程并自愿参加本研究,签署知情同意书。 

Inclusion criteria

Patients aged ≥ 18 years, ASA physical status I to III, BMI 18-30kg/m2, scheduled for elective craniotomy under general anesthesia.  

排除标准:

严重心血管疾病、肝、肾功能异常;严重肺部疾病、ARDS、支气管胸膜瘘、气胸;颅内高压;拒绝参加。 

Exclusion criteria:

Severe cardiovascular diseases, renal or liver dysfunction, severe pulmonary diseases, ARDS, bronchopleural fistula, pneumothorax, high intracranial pressure, or refusal for participation. 

研究实施时间:

Study execute time:

From2022-01-28To 2022-08-31 

征募观察对象时间:

Recruiting time:

From2022-01-28To 2022-08-31 

干预措施:

Interventions:

组别:

驱动压组

样本量:

41

Group:

driving pressure

Sample size:

干预措施:

驱动压指导PEEP

干预措施代码:

Intervention:

driving pressure–guided PEEP

Intervention code:

组别:

常规组

样本量:

41

Group:

control

Sample size:

干预措施:

常规VCV通气

干预措施代码:

Intervention:

conventional VCV

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏 

市(区县):

苏州 

Country:

China 

Province:

Jiangsu 

City:

Suzhou 

单位(医院):

苏大附一院 

单位级别:

三甲 

Institution
hospital:

First Affiliated Hospital of Soochow University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

脑松弛评分

指标类型:

主要指标 

Outcome:

brain relaxation score

Type:

Primary indicator 

测量时间点:

术中

测量方法:

Measure time point of outcome:

intraoperative

Measure method:

指标中文名:

出血量

指标类型:

主要指标 

Outcome:

blood loss

Type:

Primary indicator 

测量时间点:

术中

测量方法:

Measure time point of outcome:

intraoperative

Measure method:

指标中文名:

氧合指数

指标类型:

次要指标 

Outcome:

oxygenation index

Type:

Secondary indicator 

测量时间点:

术中

测量方法:

Measure time point of outcome:

intraoperative

Measure method:

指标中文名:

严重的肺部并发症发生率

指标类型:

次要指标 

Outcome:

incidence of significant postoperative pulmonary complications (PPCS)

Type:

Secondary indicator 

测量时间点:

术后7天

测量方法:

2级以上,需要治疗

Measure time point of outcome:

7 days postoperatively

Measure method:

grade 2+, requiring therapeutic intervention

指标中文名:

肺部并发症严重程度

指标类型:

次要指标 

Outcome:

severity of PPCS

Type:

Secondary indicator 

测量时间点:

术后7天

测量方法:

Measure time point of outcome:

7 days postoperatively

Measure method:

指标中文名:

ARDS

指标类型:

次要指标 

Outcome:

ARDS

Type:

Secondary indicator 

测量时间点:

术后7天

测量方法:

Measure time point of outcome:

7 days postoperatively

Measure method:

指标中文名:

肺不张

指标类型:

次要指标 

Outcome:

atelectasis

Type:

Secondary indicator 

测量时间点:

术后7天

测量方法:

Measure time point of outcome:

7 days postoperatively

Measure method:

指标中文名:

肺炎

指标类型:

次要指标 

Outcome:

pneumonia

Type:

Secondary indicator 

测量时间点:

术后7天

测量方法:

Measure time point of outcome:

7 days postoperatively

Measure method:

指标中文名:

低氧血症

指标类型:

次要指标 

Outcome:

hypoxemia

Type:

Secondary indicator 

测量时间点:

术后7天

测量方法:

Measure time point of outcome:

7 days postoperatively

Measure method:

指标中文名:

气胸

指标类型:

次要指标 

Outcome:

pneumothorax

Type:

Secondary indicator 

测量时间点:

术后7天

测量方法:

Measure time point of outcome:

7 days postoperatively

Measure method:

指标中文名:

胸腔积液

指标类型:

次要指标 

Outcome:

pleural effusion

Type:

Secondary indicator 

测量时间点:

术后7天

测量方法:

Measure time point of outcome:

7 days postoperatively

Measure method:

指标中文名:

入住ICU

指标类型:

次要指标 

Outcome:

ICU admission

Type:

Secondary indicator 

测量时间点:

术后7天

测量方法:

Measure time point of outcome:

7 days postoperatively

Measure method:

指标中文名:

术后出血

指标类型:

次要指标 

Outcome:

bleeding

Type:

Secondary indicator 

测量时间点:

术后24和48h

测量方法:

Measure time point of outcome:

24h, 48h postoperatively

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

动脉血

组织:

Sample Name:

arterial 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:

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):

由一名独立研究人员进行区组随机化,以1:1的比例将招募的参与者分配到两组中

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

An independent researcher performs the blocked randomization to assign recruited patients to one of two groups in a 1:1 allocation ratio.

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

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):

文章发表之后,通过联系通讯作者获取

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

The data supporting the results of this study can be assessed with approval from the corresponding author on reasonable request.

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:

纸质材料及电子材料保存在苏州大学附属第一医院

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

The paper materials and electronic materials are kept in The First Affiliated Hospital of Soochow University

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2022-01-26
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