ChiCTR1800019011 版本V1.1 版本创建时间2019/01/25 15:14:39 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：

 ChiCTR1800019011 

最近更新日期：

Date of Last Refreshed on：

 2019-01-25 15:13:51 

注册时间：

Date of Registration：

 2018-10-03 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Dry Tap During Real-time Ultrasound-guided Paramedian Spinal Injection with Patient in the Lateral Position: A Retrospective Review

Public title：

Dry Tap During Real-time Ultrasound-guided Paramedian Spinal Injection with Patient in the Lateral Position: A Retrospective Review

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Dry Tap During Real-time Ultrasound-guided Paramedian Spinal Injection with Patient in the Lateral Position: A Retrospective Review

Scientific title：

Dry Tap During Real-time Ultrasound-guided Paramedian Spinal Injection with Patient in the Lateral Position: A Retrospective Review

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_CCRB00625

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 35052735

研究负责人电话：

Study leader's
telephone：

+852 35052735

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/601

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/601

申请注册联系人通讯地址：

Dept of Anaesthesia & Intensive Care 4/F Main Clinical Block & Trauma Centre, Prince of Wales Hospital, Shatin, Hong Kong SAR, China

研究负责人通讯地址：

Dept of Anaesthesia & Intensive Care 4/F Main Clinical Block & Trauma Centre, Prince of Wales Hospital, Shatin, Hong Kong SAR, China

Applicant address：

Dept of Anaesthesia & Intensive Care 4/F Main Clinical Block & Trauma Centre, Prince of Wales Hospital, Shatin, Hong Kong SAR, China

Study leader's address：

Dept of Anaesthesia & Intensive Care 4/F Main Clinical Block & Trauma Centre, Prince of Wales Hospital, Shatin, Hong Kong SAR, 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：

香港中文大學威爾斯親王醫院

Applicant's institution：

Department of Anaesthesia & Intensive Care, Prince of Wales Hospital

研究负责人所在单位：

香港中文大學威爾斯親王醫院

Affiliation of the Leader：

Department of Anaesthesia & Intensive Care, Prince of Wales Hospital

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：

 2018.377

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：

 2018-09-04 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：

香港中文大學威爾斯親王醫院

Primary sponsor：

Department of Anaesthesia & Intensive Care, Prince of Wales Hospital

研究实施负责（组长）单位地址：

Department of Anaesthesia & Intensive Care, Prince of Wales Hospital

Primary sponsor's address：

Department of Anaesthesia & Intensive Care, Prince of Wales Hospital

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

研究疾病：

Spinal anaesthesia  

Target disease：

Spinal anaesthesia

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

单臂 

Study design：

Single arm 

研究目的：

Dry Tap During Real-time Ultrasound-guided Paramedian Spinal Injection with Patient in the Lateral Position: a case records based study  

Objectives of Study：

Dry Tap During Real-time Ultrasound-guided Paramedian Spinal Injection with Patient in the Lateral Position: a case records based study

药物成份或治疗方案详述：

Retrospective review of patients' anaesthesia records and database of real-time ultrasound guided paramedian spinal injections, performed from the non-dependent side and with the patient in lateral position over the last 10 years (2007-2017), to document the occurrence and incidence of dry tap after this technique. 

Description for medicine or protocol of treatment in detail：

Retrospective review of patients' anaesthesia records and database of real-time ultrasound guided paramedian spinal injections, performed from the non-dependent side and with the patient in lateral position over the last 10 years (2007-2017), to document the occurrence and incidence of dry tap after this technique. 

纳入标准：

Archived dataset of all adult patients who had undergone real-time ultrasound guided paramedian spinal anesthesia or Combined spinal epidural, from the non-dependent side and with the patient in lateral position, for surgical anesthesia during orthopaedics, lower abdominal, urogenital and gynaecological surgery will be retrieved for this retrospective review.

Inclusion criteria

Archived dataset of all adult patients who had undergone real-time ultrasound guided paramedian spinal anesthesia or Combined spinal epidural, from the non-dependent side and with the patient in lateral position, for surgical anesthesia during orthopaedics, lower abdominal, urogenital and gynaecological surgery will be retrieved for this retrospective review.

排除标准：

Patients with spinal deformity (Scoliosis), operated or instrumented backs

Exclusion criteria：

Patients with spinal deformity (Scoliosis), operated or instrumented backs

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 2018-10-15 00:00:00 至 To 1990-01-01 00:00:00

干预措施：

Interventions：

组别：

Case series

样本量：

 150

Group：

Case series

Sample size：

干预措施：

Collect data from patients' records once

干预措施代码：

Intervention：

Collect data from patients' records once

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：

incidence of dry tap (retrieved from patient records)

指标类型：

主要指标

Outcome：

incidence of dry tap (retrieved from patient records)

Type：

Primary indicator

测量时间点：

more than 3 minutes with the tip of spinal needle visualized sonographically within the subarachnoid space (this data will be collected from records once only)

测量方法：

failure of cerebrospinal fluid (CSF) efflux from the hub of spinal needle

Measure time point of outcome：

more than 3 minutes with the tip of spinal needle visualized sonographically within the subarachnoid space (this data will be collected from records once only)

Measure method：

failure of cerebrospinal fluid (CSF) efflux from the hub of spinal needle

指标中文名：

slow cerebrospinal fluid (CSF) efflux [retrieved from patient records]

指标类型：

次要指标

Outcome：

slow cerebrospinal fluid (CSF) efflux [retrieved from patient records]

Type：

Secondary indicator

测量时间点：

within 1 to 3 minutes of the removal of spinal needle stylet (this data will be collected once only)

测量方法：

efflux of CSF within 1 to 3 minutes after the removal of spinal needle stylet with the needle tip visualized sonographically within the subarachnoid space

Measure time point of outcome：

within 1 to 3 minutes of the removal of spinal needle stylet (this data will be collected once only)

Measure method：

efflux of CSF within 1 to 3 minutes after the removal of spinal needle stylet with the needle tip visualized sonographically within the subarachnoid space

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 18 岁 years
最大 Max age 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：

N/A

Blinding：

N/A

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

否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：

  2018-10-21 13:22:54