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硬脑膜开放期间的保护性肺通气对颅内肿瘤手术局部脑氧饱和度的影响
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注册号:

Registration number:

ChiCTR1900025632 

最近更新日期:

Date of Last Refreshed on:

2019-09-03 

注册时间:

Date of Registration:

2019-09-03 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

硬脑膜开放期间的保护性肺通气对颅内肿瘤手术局部脑氧饱和度的影响 

Public title:

The effects of protective lung ventilation on regional cerebral oxygen saturation in intracranial tumor operative during dura opening 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

硬脑膜开放期间的保护性肺通气对颅内肿瘤手术局部脑氧饱和度的影响 

Scientific title:

The effects of protective lung ventilation on regional cerebral oxygen saturation in intracranial tumor operative during dura opening 

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:

李金路 

研究负责人:

刘海瑞 

Applicant:

Jinlu Li 

Study leader:

Hairui Liu 

申请注册联系人电话:

Applicant telephone:

+86 18251192356 

研究负责人电话:

Study leader's telephone:

+86 13584820904 

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:

lijinlu888@163.com 

研究负责人电子邮件:

Study leader's E-mail:

hrhr218@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:

中国江苏省苏州市三香路1055号 

研究负责人通讯地址:

中国江苏省苏州市三香路1055号 

Applicant address:

1055 Sanxiang Road, Suzhou, Jiangsu, China  

Study leader's address:

1055 Sanxiang Road, Suzhou, Jiangsu, China  

申请注册联系人邮政编码:

Applicant postcode:

215004 

研究负责人邮政编码:

Study leader's postcode:

215004 

申请人所在单位:

苏州大学附属第二医院 

Applicant's institution:

The Second Affiliated Hospital of Soochow 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:

JD-LK-2018-077-01 

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:

苏州大学附属第二医院伦理委员会 

Name of the ethic committee:

The Ethic Committee of the Second Affiliated Hospital of Soochow University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-11-23 

伦理委员会联系人:

华雯妍、黄倩倩 

Contact Name of the ethic committee:

Wenyan Hua, Qianqian Huang 

伦理委员会联系地址:

苏州市三香路1055号苏州大学附属第二医院1号楼1608 

Contact Address of the ethic committee:

Room 1608, Building 1, 1055 Sanxiang Road, Suzhou, Jiangsu, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 0512 67783682 

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:

苏州大学附属第二医院 

Primary sponsor:

The Second Affiliated Hospital of Soochow University 

研究实施负责(组长)单位地址:

中国江苏省苏州市三香路1055号 

Primary sponsor's address:

1055 Sanxiang Road, 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):

苏州大学附属第二医院

具体地址:

三香路1055号

Institution
hospital:

The Second Affiliated Hospital of Soochow University

Address:

1055 Sanxiang Road

经费或物资来源:

自筹 

Source(s) of funding:

Self-finance 

研究疾病:

颅内肿瘤手术 

Target disease:

intracranial tumor surgery 

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:

探索性研究/预试验 

Study phase:

研究目的:

本研究的目的是确定术中肺保护策略是否能改善颅内肿瘤手术患者局部脑氧饱和度,术中肺保护通气策略是否能有效和安全地用于神经外科病人进行开颅肿瘤切除手术。 

Objectives of Study:

This study aims to determine whether intraoperative pulmonary protection strategy can improve regional cerebral oxygen saturation in patients undergoing intracranial tumor surgery. Whether intraoperative pulmonary protection strategy can be used effectively and safely in neurosurgical patients undergoing craniotomy for tumor resection. 

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. 择期行颅内肿瘤切除术的患者,年龄小于65岁; 2. 肿瘤最大直径2 cm~5 cm; 3. ASA分级Ⅰ-Ⅱ级; 4. 18.5<BMI<28; 5. 格拉斯哥昏迷量表得分8分以上。 

Inclusion criteria

1. Patients scheduled to receive elective intracranial primary intra-axial tumor resection who are younger than 65 years and elder than 18 years; 2. The maximum diameter of the tumor is 2~5 cm; 3. ASA class for I-II; 4. 18.5 < BMI < 28; 5. Glasgow Coma Scale score of more than 8 points. 

排除标准:

1. 存在慢性肺部疾病、肺部感染或者急性呼吸衰竭等肺合并症的患者; 2. 有肺部手术史者; 3. 合并其他严重脑、心、肝、肾脏疾病患者; 4. 术前颅神经损伤或者其他影响呼吸的神经损伤者; 5. 孕妇; 6. 拒绝参加本研究者。 

Exclusion criteria:

1. Patients with chronic lung diseasepulmonary infection and other severe pulmonary complications such as acute respiratory failure; 2. Patients with a history of pulmonary surgery; 3. Patients with severe brain, heart, liver and kidney diseases; 4. Patients with nerve injury affecting breathing preoperative; 5. Pregnant women; 6. Refuse to participate in the researcher. 

研究实施时间:

Study execute time:

From2019-09-02To 2020-09-01 

干预措施:

Interventions:

组别:

对照组

样本量:

27

Group:

C group

Sample size:

干预措施:

潮气量为理想体重8ml/kg

干预措施代码:

Intervention:

VT set at 8ml/kg of ideal body weight

Intervention code:

组别:

肺保护组

样本量:

27

Group:

P group

Sample size:

干预措施:

硬膜开放期间,个性化PEEP联合潮气量为理想体重6ml/kg

干预措施代码:

Intervention:

VT will be set at 6 ml/kg of ideal body weight combined with individualized PEEP (PEEPx) during intraoperative dura mater opening

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):

苏州大学附属第二医院 

单位级别:

三级甲等医院 

Institution
hospital:

The Second Affiliated Hospital of Soochow University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

局部脑氧饱和度

指标类型:

主要指标 

Outcome:

rSO2

Type:

Primary indicator 

测量时间点:

麻醉前(T0)、硬膜开放前(T1)、硬膜关闭后(T2) 、术毕24 h(T3)

测量方法:

Measure time point of outcome:

T0: before anesthesia; T1: before dura opening; T2: after dura closing; T3: 24h after surgery.

Measure method:

指标中文名:

动脉氧分压

指标类型:

次要指标 

Outcome:

Partial pressure of oxygen in arterial blood

Type:

Secondary indicator 

测量时间点:

麻醉前(T0)、硬膜开放前(T1)、硬膜关闭后(T2) 、术毕24 h(T3)

测量方法:

Measure time point of outcome:

T0: before anesthesia; T1: before dura opening; T2: after dura closing; T3: 24h after surgery.

Measure method:

指标中文名:

动脉二氧化碳分压

指标类型:

次要指标 

Outcome:

Partial pressure of carbon dioxide in arterial blood

Type:

Secondary indicator 

测量时间点:

麻醉前(T0)、硬膜开放前(T1)、硬膜关闭后(T2) 、术毕24 h(T3)

测量方法:

Measure time point of outcome:

T0: before anesthesia; T1: before dura opening; T2: after dura closing; T3: 24h after surgery.

Measure method:

指标中文名:

动脉氧合指数

指标类型:

次要指标 

Outcome:

Oxygenation index in arterial blood

Type:

Secondary indicator 

测量时间点:

麻醉前(T0)、硬膜开放前(T1)、硬膜关闭后(T2) 、术毕24 h(T3)

测量方法:

Measure time point of outcome:

T0: before anesthesia; T1: before dura opening; T2: after dura closing; T3: 24h after surgery.

Measure method:

指标中文名:

动脉乳酸水平

指标类型:

次要指标 

Outcome:

Lactic acid level in arterial blood

Type:

Secondary indicator 

测量时间点:

麻醉前(T0)、硬膜开放前(T1)、硬膜关闭后(T2) 、术毕24 h(T3)

测量方法:

Measure time point of outcome:

T0: before anesthesia; T1: before dura opening; T2: after dura closing; T3: 24h after surgery.

Measure method:

指标中文名:

平均动脉压

指标类型:

次要指标 

Outcome:

Mean arterial pressure

Type:

Secondary indicator 

测量时间点:

麻醉前(T0)、硬膜开放前(T1)、硬膜关闭后(T2) 、术毕24 h(T3)

测量方法:

Measure time point of outcome:

T0: before anesthesia; T1: before dura opening; T2: after dura closing; T3: 24h after surgery.

Measure method:

指标中文名:

肺部超声评分

指标类型:

次要指标 

Outcome:

Pulmonary ultrasound scores

Type:

Secondary indicator 

测量时间点:

麻醉前(T0)、术毕24 h(T3)

测量方法:

Measure time point of outcome:

T0: before anesthesia; T3: 24h after surgery.

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 65 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):

通过SPSS 22.0产生随机数列。

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

Random numbers generated through SPSS 22.0.

盲法:

对参试者、结果评价者施盲。

Blinding:

The anesthesiologist who is responsible for the anesthesia implementation will know the grouping but not participate in the follow-up visit, the neurosurgeon who evaluates brain relaxation will be blinded to the group allocation and the patients and the outcome assessor are all blinded to the grouping.

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):

2020年10月将原始数据公布在中国临床试验注册中心 http://www.chictr.org.cn/usercenter.aspx

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

IPD will be shared on website Chinese clinical trial registry: http://www.chictr.org.cn/usercenter.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:

数据采集和管理通过ResMan实施

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

Data collection and Management is implemented through ResMan System

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-09-03
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