ChiCTR1800016580 版本V1.0 版本创建时间2018/09/13 11:22:10 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR1800016580 

最近更新日期：

Date of Last Refreshed on：

2018-06-11 03:06:22 

注册时间：

Date of Registration：

2018-05-24 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

實時超聲波引導脊椎麻醉：評估使用橫向平面超聲波檢查的新技術

Public title：

Real-time Ultrasound-guided Spinal Anaesthesia: Evaluation of a novel Transverse In-plane Technique

注册题目简写：

English Acronym：

研究课题的正式科学名称：

實時超聲波引導脊椎麻醉：評估使用橫向平面超聲波檢查的新技術

Scientific title：

Real-time Ultrasound-guided Spinal Anaesthesia: Evaluation of a novel Transverse In-plane Technique

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：

CUHK_CCRB00609

申请注册联系人：

Winnie Samy 

研究负责人：

Prof Manoj Kumar Karmakar 

Applicant：

Winnie Samy 

Study leader：

Prof Manoj Kumar Karmakar 

申请注册联系人电话：

Applicant telephone：

+852 3505 2735

研究负责人电话：

Study leader's telephone：

+852 3505 2735

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：

wsamy@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

karmakar@cuhk.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

https://www2.ccrb.cuhk.edu.hk/registry/public/555

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

https://www2.ccrb.cuhk.edu.hk/registry/public/555

申请注册联系人通讯地址：

Rm 04A49, 4/F Main Clinical Block & Trauma Centre, Prince of Wales Hospital, Shatin, NT, China

研究负责人通讯地址：

Rm 04A49, 4/F Main Clinical Block & Trauma Centre, Prince of Wales Hospital, Shatin, NT, China

Applicant address：

Rm 04A49, 4/F Main Clinical Block & Trauma Centre, Prince of Wales Hospital, Shatin, NT, China

Study leader's address：

Rm 04A49, 4/F Main Clinical Block & Trauma Centre, Prince of Wales Hospital, Shatin, NT, 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：

Department of Anaesthesia & Intensive Care, Prince of Wales Hospital

Applicant's institution：

Department of Anaesthesia & Intensive Care, Prince of Wales Hospital

研究负责人所在单位：

Department of Anaesthesia & Intensive Care, Prince of Wales Hospital

Affiliation of the Leader：

Department of Anaesthesia & Intensive Care, Prince of Wales Hospital

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

CREC.2018.216-T

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：

Joint CUHK-NTEC Clinical Research Ethics Committee

Name of the ethic committee：

Joint CUHK-NTEC Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2018-05-03 00:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

伦理委员会联系地址：

Contact Address of the ethic committee：

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：

Department of Anaesthesia & Intensive Care, CUHK

Primary sponsor：

Department of Anaesthesia & Intensive Care, CUHK

研究实施负责（组长）单位地址：

Department of Anaesthesia & Intensive Care, CUHK

Primary sponsor's address：

Department of Anaesthesia & Intensive Care, CUHK

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Department of Anaesthesia & Intensive Care, CUHK

Source(s) of funding：

Department of Anaesthesia & Intensive Care, CUHK

Target disease：

Spinal anaesthesia, lower limb surgery, lower abdominal surgery, gynaecological surgery, urogenital surgery

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 诊断试验新技术临床试验 

Study phase：

Diagnostic New Technique Clincal Study

研究设计：

单臂 

Study design：

Single arm 

研究目的：

評估使用橫向平面超聲波檢查的新技術  

Objectives of Study：

Evaluation of a novel Transverse In-plane Technique

药物成份或治疗方案详述：

Spinal anaesthsia (SA) is usually performed using surface anatomical landmarks, fascial clicks and visualizing the free flow of cerebrospinal fluid (CSF). Real time ultrasound guided SA has been most frequently reported using Paramedian sagittal oblique acoustic window. However, paramedian sagittal oblique in-plane approach has limitations such as slower CSF efflux, and dry tap in the elderly possibly due to the technique being performed from non-dependent side and lower CSF pressure in the elderly. To date there are no data describing the use of transverse interspinous acoustic windows for real time ultrasound guided in-plane approach for SA from dependent side. This study will evaluate the feasibility and the technical ease of performing SA by observing the time taken for the performance of SA and the CSF efflux time using the technique of single operator, in-plane apporach from dependent side under real time ultrasound guidance in a transverse interspinous view. 

Description for medicine or protocol of treatment in detail：

Spinal anaesthsia (SA) is usually performed using surface anatomical landmarks, fascial clicks and visualizing the free flow of cerebrospinal fluid (CSF). Real time ultrasound guided SA has been most frequently reported using Paramedian sagittal oblique acoustic window. However, paramedian sagittal oblique in-plane approach has limitations such as slower CSF efflux, and dry tap in the elderly possibly due to the technique being performed from non-dependent side and lower CSF pressure in the elderly. To date there are no data describing the use of transverse interspinous acoustic windows for real time ultrasound guided in-plane approach for SA from dependent side. This study will evaluate the feasibility and the technical ease of performing SA by observing the time taken for the performance of SA and the CSF efflux time using the technique of single operator, in-plane apporach from dependent side under real time ultrasound guidance in a transverse interspinous view. 

纳入标准：

Patients who are between 20 to 85 years old, of American Society of Anaesthesiology (ASA) physical status classification I-III, and scheduled to undergo elective groin, lower limb, lower abdominal surgical, gynaecological and urogenital procedures under spinal anaesthesia.

Inclusion criteria

Patients who are between 20 to 85 years old, of American Society of Anaesthesiology (ASA) physical status classification I-III, and scheduled to undergo elective groin, lower limb, lower abdominal surgical, gynaecological and urogenital procedures under spinal anaesthesia.

排除标准：

Patient refusal or unwilling to participate, ASA physical status >III, spinal deformity, previous spine surgery, pregnancy, coagulopathy, allergy to local anaesthetic drugs, skin infection at the site of needle insertion, severe cardiac disease such as atrial stenosis, atrial fibrillation, autonomica dysfunction, and sepsis.

Exclusion criteria：

Patient refusal or unwilling to participate, ASA physical status >III, spinal deformity, previous spine surgery, pregnancy, coagulopathy, allergy to local anaesthetic drugs, skin infection at the site of needle insertion, severe cardiac disease such as atrial stenosis, atrial fibrillation, autonomica dysfunction, and sepsis.

研究实施时间：

Study execute time：

从 From 1990-01-01 00:00:00至 To 1990-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2018-06-01 00:00:00 至 To 1990-01-01 00:00:00  

干预措施：

Interventions：

组别：

Case series

样本量：

30

Group：

Case series

Sample size：

干预措施：

Nil

干预措施代码：

Intervention：

Nil

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China 

Province：

Hong Kong SAR 

City：

 

单位(医院)：

Prince of Wales Hospital 

单位级别：

Prince of Wales Hospital 

Institution
hospital：

Prince of Wales Hospital

Level of the institution：

Prince of Wales Hospital

测量指标：

Outcomes：

指标中文名：

Feasibility & technical ease of doing spinal anaesthesia under real time ultrasound guided transverse in-plane approach from the dependent side

指标类型：

主要指标

Outcome：

Feasibility & technical ease of doing spinal anaesthesia under real time ultrasound guided transverse in-plane approach from the dependent side

Type：

Primary indicator

测量时间点：

once during spinal anaesthesia

测量方法：

Observing the time taken for the performance of spinal anaesthesia (in minute)

Measure time point of outcome：

once during spinal anaesthesia

Measure method：

Observing the time taken for the performance of spinal anaesthesia (in minute)

指标中文名：

Cerebrospinal fluid (CSF) efflux time

指标类型：

主要指标

Outcome：

Cerebrospinal fluid (CSF) efflux time

Type：

Primary indicator

测量时间点：

once during spinal anesthesia

测量方法：

The time taken for the first drop of CSF to efflux from the spinal needle hub after removal of the stylet from the spinal needle (in seconds).

Measure time point of outcome：

once during spinal anesthesia

Measure method：

The time taken for the first drop of CSF to efflux from the spinal needle hub after removal of the stylet from the spinal needle (in seconds).

指标中文名：

Rate of successful attempt, number of spinal needle pass, patient satisfaction score, any intraoperative or postoperative complications in the next 24 hours

指标类型：

次要指标

Outcome：

Rate of successful attempt, number of spinal needle pass, patient satisfaction score, any intraoperative or postoperative complications in the next 24 hours

Type：

Secondary indicator

测量时间点：

within 24 hours after Spinal Anaesthesia

测量方法：

successful SA defined as achieving sensor & motor blockade after SA & able to complete the surgery. Patient satisfaction score evaluated on the scale of Verbal Rating scale: 0(not satisfied) to 100 (very satisfied)

Measure time point of outcome：

within 24 hours after Spinal Anaesthesia

Measure method：

successful SA defined as achieving sensor & motor blockade after SA & able to complete the surgery. Patient satisfaction score evaluated on the scale of Verbal Rating scale: 0(not satisfied) to 100 (very satisfied)

采集人体标本：

Collecting sample(s)
from participants：

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 20 岁 years
最大 Max age 85 岁 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）：

N/A

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

N/A

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

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)：

是否共享原始数据：

IPD sharing

No

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）：

Not stated

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

Not stated

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：

Not stated

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

Not stated

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2018-06-11 03:06:22