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不同流量经鼻吸氧在唤醒开颅手术麻醉中颅内压控制的比较
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注册号:

Registration number:

ChiCTR1800016621 

最近更新日期:

Date of Last Refreshed on:

2018-06-13 

注册时间:

Date of Registration:

2018-06-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

不同流量经鼻吸氧在唤醒开颅手术麻醉中颅内压控制的比较 

Public title:

Comparison of intracranial pressure control by different flow of transnasal oxygen during anesthesia of awake craniotomy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

不同流量经鼻吸氧在唤醒开颅手术麻醉中颅内压控制的比较 

Scientific title:

Comparison of intracranial pressure control by different flow of transnasal oxygen during anesthesia of awake craniotomy 

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:

李琼 

研究负责人:

顾华华 

Applicant:

LI QIONG 

Study leader:

GU HUAHUA 

申请注册联系人电话:

Applicant telephone:

+86 13917307865 

研究负责人电话:

Study leader's telephone:

+86 13918121092 

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:

li.qiong@wo.cn 

研究负责人电子邮件:

Study leader's E-mail:

test@aj.com.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:

上海市乌鲁木齐中路12号复旦大学附属华山医院麻醉科 

研究负责人通讯地址:

上海市乌鲁木齐中路12号复旦大学附属华山医院麻醉科 

Applicant address:

12 Wulumuqi Middle Road, Shanghai, China 

Study leader's address:

12 Wulumuqi Middle Road, Shanghai, China 

申请注册联系人邮政编码:

Applicant postcode:

200040 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

复旦大学附属华山医院 

Applicant's institution:

Huashan Hospital, Fudan 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:

KY2018-232 

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:

复旦大学附属华山医院伦理审查委员会 

Name of the ethic committee:

Huashan Hospital Affiliated to Fudan University Research Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

吴翠云 

Contact Name of the ethic committee:

Wu Cuiyun 

伦理委员会联系地址:

上海市乌鲁木齐中路12号 

Contact Address of the ethic committee:

12 Wulumuqi Middle Road, Shanghai, 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:

复旦大学附属华山医院 

Primary sponsor:

Huashan Hospital, Fudan University 

研究实施负责(组长)单位地址:

上海市乌鲁木齐中路12号 

Primary sponsor's address:

12 Wulumuqi Middle Road, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

复旦大学附属华山医院

具体地址:

上海市乌鲁木齐中路12号

Institution
hospital:

Huashan Hospital Fudan University

Address:

12 Wulumuqi Middle Road, Shanghai, China

经费或物资来源:

自筹 

Source(s) of funding:

self funding 

研究疾病:

唤醒开颅手术麻醉 

Target disease:

Anesthesia of awake 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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

探索HFNO用于唤醒开颅手术麻醉中的可行性。以改进目前术中二氧化碳偏高状况,为术者提供更为满意的颅内压,并避免鼻咽通气道放置时所致局部的损伤。寻求最佳吸入氧流量,为患者在达到最佳通气状态的同时提供更为满意的舒适度。 

Objectives of Study:

To explore the feasibility of HFNO in anesthesia of awake craniotomy.In order to improve the current situation of high intraoperative carbon dioxide, more satisfactory intracranial pressure was provided for the operator, and local damage caused by nasopharyngeal airway placement was avoided.The optimal inspiratory oxygen flow is sought to provide patients with more satisfactory comfort while achieving optimal ventilation. 

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) 14-70岁,男女不限 2) 功能区(语言和/或运动区)占位或癫痫病灶,神经外科手术需做唤醒麻醉 3) ASAⅠ-Ⅱ级 4) 术前无失语或肌力改变 5) 能理解及签署知情同意书者 

Inclusion criteria

1) Patients aged 14-70 years(gender is not limited) 2) planning to receive the elective neurosurgery of awake craniotomy in the brain function area or epilepsy area ; 3) ASA I~II; 4) No aphasia or myodynamia changes were observed before surgery; 5) Informed consent has been signed.  

排除标准:

1) 存在严重的脏器疾患,处于失代偿期(如严重的内科合并症): a)心功能≥ 3级 b)呼吸功能衰竭 c)肝肾功能不全 d)血液系统疾病 e)未控制的高血压 f)存在COPD病史及肺纤维化,术前长期大量吸烟的患者 g)术前严重颅内高压,已有脑疝的患者 2) 对手术极度焦虑恐惧,估计术中难以配合者 3) 术前意识,认知功能障碍者 4) 术前沟通交流障碍,失语者 5) 病理性肥胖(BMI≥30)合并阻塞性睡眠呼吸暂停综合征者 6) 临床评估为困难气道者 7) 脑胶质瘤合并其他系统肿瘤的患者 8) 女性妊娠患者 9) 近3月参与其他临床试验者 

Exclusion criteria:

1. There is a serious system disease and it is in the period of decompensation (such as severe medical complications) : 1) cardiac function ≥ grade 3; 2) respiratory failure; 3) hepatic and renal insufficiency; 4) diseases of the blood system; 5) uncontrolled hypertension; 6) patients with a history of COPD and pulmonary fibrosis, who smoked heavily for a long time before surgery; 7) patients with severe intracranial hypertension and cerebral hernia before surgery; 2. extreme anxiety and fear of surgery, and it is estimated that it is difficult to cooperate in surgery; 3. patients with preoperative consciousness and cognitive dysfunction; 4. preoperative communication disorder, aphasia; 5. patients with pathological obesity (BMI greater than 30) and obstructive sleep apnea syndrome; 6. patients with difficulty to intubation in clinical evaluation; 7. patients with glioma combined with other systemic tumors; 8. female pregnancy; 9. participated in other clinical trials in recent 3 months. 

研究实施时间:

Study execute time:

From2018-06-18To 2019-07-31 

征募观察对象时间:

Recruiting time:

From2018-06-18To 2019-07-31 

干预措施:

Interventions:

组别:

组 A

样本量:

24

Group:

Group A

Sample size:

干预措施:

经鼻吸氧20L/min

干预措施代码:

Intervention:

Nasal oxygen flow rate 20L/min

Intervention code:

组别:

组 B

样本量:

24

Group:

Group B

Sample size:

干预措施:

经鼻吸氧40L/min

干预措施代码:

Intervention:

Nasal oxygen flow rate 40L/min

Intervention code:

组别:

组 C

样本量:

24

Group:

Group C

Sample size:

干预措施:

放置鼻咽通气道置声门上

干预措施代码:

Intervention:

Place the tube between epiglottis and vocal cords through nasal cavity

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

复旦大学附属华山医院 

单位级别:

三级甲等医院 

Institution
hospital:

Huashan Hospital Fudan University  

Level of the institution:

Tertiary Hospital 

测量指标:

Outcomes:

指标中文名:

颅内压

指标类型:

主要指标 

Outcome:

Intracranial pressure

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

动脉血二氧化碳分压

指标类型:

主要指标 

Outcome:

PaCO2

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

动脉血氧分压

指标类型:

主要指标 

Outcome:

PaO2

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

脉搏氧饱和度

指标类型:

主要指标 

Outcome:

SpO2

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

警觉-镇静评分

指标类型:

主要指标 

Outcome:

OAA/S score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

脑电双频指数

指标类型:

主要指标 

Outcome:

BIS

Type:

Primary 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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 14 years
最大 Max age 70 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):

由麻醉护士采用随机数字表法以及随机余数分组法

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

Using the random number table method and the random remainder grouping method by anesthesia nurse

盲法:

Blinding:

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:

试验完成后6个月内公开/Within six months after the trial complete

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):

2020-06-01采用Chictr.org.cn网络平台共享

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

IPD will be shared on 1 June 2020 on web: Chictr.org.cn

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:

CRF,电子采集和管理系统,并由研究助理人员负责管理

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

Data collection and management system include a CRF and an electronic data capture,which will be saved and managed by a research assistant

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-06-12
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