| CTRI Number |
CTRI/2014/09/005043 [Registered on: 22/09/2014] Trial Registered Prospectively |
| Last Modified On: |
30/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of size of big vein of neck and relationship of this vein with big artery, by sonography |
|
Scientific Title of Study
|
Ultrasonographic assessment of cross-sectional area of internal jugular vein and relationship of internal jugular vein and carotid artery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sohan Solanki |
| Designation |
Assistant Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anaesthesia, Critical Care and Pain,
2nd floor, Main Building, Tata Memorial Hospital, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
022-24177053 |
| Fax |
|
| Email |
sohan.solanki@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sohan Solanki |
| Designation |
Assistant Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anaesthesia, Critical Care and Pain,
2nd floor, Main Building, Tata Memorial Hospital, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
022-24177053 |
| Fax |
|
| Email |
sohan.solanki@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sohan Solanki |
| Designation |
Assistant Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anaesthesia, Critical Care and Pain,
2nd floor, Main Building, Tata Memorial Hospital, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
022-24177053 |
| Fax |
|
| Email |
sohan.solanki@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre |
| Address |
Dr E Borges Road, Parel, Mumbai |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sohan Solanki |
Department of Anaesthesiology, Critical Care and Pain, 2nd floor, Tata Memorial Centre |
Dr E Borges Road, Parel, Mumbai
Mumbai
MAHARASHTRA |
022-24177053
sohan.solanki@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instititional Ethics Committee, Tata Memorial Hospital Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal Healthy Volunteers of both sex between age 18 to 60 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Ultrasonographic assessment |
Ultrasonographic assessment of cross sectional area of internal jugular vein in supine, Trendelenberg position and during Valsalva, and relationship of internal jugular vein and carotic artery during head rotation to contralateral side from neurtal to 30, 45 and 90 degree |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Normal healthy volunteers between ages of 18 to 60 years |
|
| ExclusionCriteria |
| Details |
1. Volunteer with a previous history of IJV cannulation.
2. Volunteer with known allergic reactions to ultrasound jelly.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. The maximum cross-sectional area of the internal jugular vein on ultrasound
2. Relationship of the internal jugular vein with carotid artery (percentage of overlap of carotid artery and relative position of internal jugular vein and carotid artery) |
1. In supine from sitting position, Trendelenburg position and during Valsalva maneuver.
2. During neutral head position, 30, 45 and 90 degree head rotation to contralateral side
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2014 |
| Date of Study Completion (India) |
25/01/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The internal jugular vein is a common site for central venous access. In the absence of ultrasound imaging, this procedure is traditionally performed using external landmarks and the carotid artery pulsation as a guide. The technique has been associated with a 6–9% rate of carotid artery puncture. Carotid artery puncture may be due, in part, to anatomic variation of the internal jugular vein specifically its size, location and relationship to the carotid artery. Ultrasound studies suggest that clinical maneuvers such as the Valsalva, an abdominal binder, or the Trendelenburg position alone or in combination, increase the cross-sectional area of the internal jugular vein, whereas extreme head rotation, carotid palpation, and needle advancement can distort or collapse the vein. |