Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00636

2 Trial Registration Date

2018-11-27

i Registration Status

Prospective

3 Secondary IDs

CREC. 2018.414

4 Source(s) of Funding

Department of Anaesthesia & Intensive Care, CUHK

5 Primary Sponsor

Department of Anaesthesia & Intensive Care, CUHK

6 Secondary Sponsor

NA

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Winnie Samy

ii Address

RM 04C49, 4th floor, Main Clinical Block & Trauma Centre,
Prince of Wales Hospital,
Shatin,
NT

iii Phone

35052735

iv Email

wsamy@cuhk.edu.hk

v Affiliation

Department of Anaesthesia & Intensive Care

vi Country

Hong Kong SAR, China

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Prof Manoj Kumar Karmakar

ii Address

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

iii Phone

35052735

iv Email

karmakar@cuhk.edu.hk

v Affiliation

Department of Anaesthesia & Intensive Care

vi Country

Hong Kong SAR, China

9 Official Scientific Title of the Study

Localization of the Individual Elements of the Brachial Plexus above the Clavicle Using High Definition Ultrasound Imaging - Description of a Stepwise Scanning Technique

10 Public Title

Localization of the Individual Elements of the Brachial Plexus above the Clavicle Using High Definition Ultrasound Imaging - Description of a Stepwise Scanning Technique

i Public Title in Chinese 研究名稱

描述使用高清晰度超聲波從鎖骨上方逐步掃描臂叢神經個體元素的定位掃描技術

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong SAR, China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2018-11-02

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CREC.2018.414

14 Medical Condition Being Studied

Healthy volunteers

15 Intervention

i Types of intervention

Other

Please specify

Technique - High definition ultrasound imaging

ii Description/ name of Intervention/article

To describe and evaluate a stepwise scanning technique to systematiccally identify the individual elements of the brachial plexus above the clavicle using high definition ultrasound. 5 healthy volunteers over 18 years old will be recruited.

iii Dosage form of the intervention

not a pharmaceutical study

iv Dosage of the intervention

not a pharmaceutical study

v Duration of the intervention

20- 30 minutes

vi Frequency of the intervention

once

16 Comparative Treatments

i Description/ name of comparative treatments

Not applicable - this is not a comparative study.

ii Dosage form of the comparative treatments

not applicable

iii Dosage of the comparative treatments

not applicable

iv Duration of the comparative treatments

not applicable

v Frequency of the comparative treatments

not applicable

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

healthy adult volunteers aged 18 years or above

ii Exclusion Criteria

BMI >30, short neck, neck deformity and previous surgery on the neck.

iii Age Minimum

18

iv Age Maximum

70

v Gender

Both Male and Female

18 Study Type

Observational

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

4

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2018-11-29

21 Target Sample Size

5

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

The individual elements of the Brachial Plexus i.e. C5 – T1 nerve roots, bifurcation (septation) of the cervical nerve roots if any, formation of the upper, middle and lower trunks, the anterior and posterior divisions of the individual trunks, and the suprascapular nerve.

ii The metric or method of measurement used

Optimized ultrasound images during each step of the scan for visualization (yes or no) of the individual elements of the brachial plexus

iii The timepoint(s) of primary interest

once during ultrasound imaging

24 Secondary Outcome

i The Name of the outcome

nil

ii The metric or method of measurement used

nil

iii The timepoint(s) of primary interest

nil

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2019-08-08

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2018-11-27