| CTRI Number |
CTRI/2025/02/080217 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
02/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study For A Year To Compare Two Methods Of Guiding A Needle Into The Right Internal Jugular Vein Using Ultrasound. |
|
Scientific Title of Study
|
Comparision Of Modified Combined Long And Short Axis Versus Oblique Axis In Plane Method For Ultrasound Guided Right Internal Jugular Vein Cannulation In Adult Patients-One Year Randomised Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kavya Kalluri |
| Designation |
Junior Resident |
| Affiliation |
KLE Dr Prabhakar Kore Hospital and MCH |
| Address |
Department Of Anesthesiology
JN Medical College
Belgavi-10
Belgaum
KARNATAKA
590010
India |
| Phone |
6300718816 |
| Fax |
|
| Email |
kavyakalluri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M G Dhorigol |
| Designation |
Professor |
| Affiliation |
KLE Dr Prabhakar Kore Hospital and MCH |
| Address |
Department Of Anesthesiology
JN Medical College
Belgavi
Belgaum
KARNATAKA
590010
India |
| Phone |
6364755253 |
| Fax |
|
| Email |
mallappadhorigol@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M G Dhorigol |
| Designation |
Professor |
| Affiliation |
KLE Dr Prabhakar Kore Hospital and MCH |
| Address |
Department Of Anesthesiology
JN Medical College
Belgavi
Belgaum
KARNATAKA
590010
India |
| Phone |
6364755253 |
| Fax |
|
| Email |
mallappadhorigol@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesiology Jawaharlal Nehru Medical College Belagavi Karnataka 590010 |
|
|
Primary Sponsor
|
| Name |
Dr Kavya Kalluri |
| Address |
Department Of Anaesthesiology, JN Medical college, Belagavi-10,Karnataka Belgaum Karnataka |
| Type of Sponsor |
Other [Self] |
|
|
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 Kavya Kalluri |
KLES JN Medical College Belagavi |
Department Of Anaesthesiology, JNMC, Nehru Nagar, KLE Prabhakar Kore
Hospital, JNMC Belagavi-10,Karnataka
Belgaum
KARNATAKA |
6300718816
kavyakalluri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Instituitional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I959||Hypotension, unspecified, (2) ICD-10 Condition: I959||Hypotension, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Modified Combined Long And Short Axis |
The USG probe Is Placed In The Supraclavicular Fossa. The Needle Is Inserted At An Angle of 30 Degrees With Short Axis Out Of Plane And Needle Tip Is Seen As A Point.Now The Probe Is Rotated 90 Degrees Clockwise And Anterior Wall Of IJV Is Punctured In Long Axis. |
| Intervention |
Oblique Axis In Plane Method |
USG Probe Is Placed On The IJV At Mid Neck Level Cross Section of CCA And IJV Are Visualized. After Short Axis View Is Obtained, Probe Is Rotated 45 Degrees With an Orientation Marker Medially, Needle is Inserted Laterally To Medially in Inplane Technique |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients who need right IJV catheterization |
|
| ExclusionCriteria |
| Details |
Failure To Provide Consent
Possible Structural Abnormalities In The Neck
History Of Previous Surgical Intervention Or Radiotherapy Near The Cannulation Site
Recent Cervical Trauma With Present Neck Immobilization
Patients With Huge Masses or Lymph Nodes In The Right Neck
Infection signs, Neck scar, Subcutaneous emphysema Or Subcutaneous Haematoma close To Puncture Site
History Of Right IJV Catheterization During Past 1 Month
Presence Of Superior Vena Cava Syndrome
IJV Plaque Thrombosis
Patients With Anatomical Variations And NO Right Internal Jugular Vein |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| First Attempt Success Rate |
Perioperative Intraoperative Postoperative 0 Minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number Of Needle Insertion Attempts
The Procedure Time
Mechanical Complications |
Perioperative Intraoperative Postoperative 0 Minutes |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
21/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
21/02/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Comparision of the Two Methods Of IJV Cannulation In Adult Patients Is being Done To Identify The Superior Method. |