| CTRI Number |
CTRI/2026/01/101403 [Registered on: 16/01/2026] Trial Registered Prospectively |
| Last Modified On: |
14/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE COMPARATIVE OBSERVATIONAL STUDY |
| Study Design |
Other |
|
Public Title of Study
|
COMPARISON OF PROBE POSITIONS FOR ULTRASOUND GUIDED RIGHT INTERNAL JUGULAR VEIN CANNULATION IN ADULT PATIENTS IN INTENSIVE CARE UNIT |
|
Scientific Title of Study
|
COMPARISON OF SUCCESS OF LONG AXIS VERSUS SHORT AXIS APPROACH FOR ULTRASOUND GUIDED RIGHT INTERNAL JUGULAR VEIN CANNULATION IN ADULT PATIENTS IN INTENSIVE CARE UNIT |
| 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 UDIT BATHLA |
| Designation |
POSTGRADUATE RESIDENT |
| Affiliation |
JSS MEDICAL COLLEGE AND HOSPITAL, MYSORE, KARNATAKA |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE
JSS HOSPITAL
MYSORE
KARNATAKA
Mysore
KARNATAKA
570004
India |
| Phone |
9501162220 |
| Fax |
|
| Email |
uditbathla1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr GIRISH BK |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
JSS MEDICAL COLLEGE AND HOSPITAL, MYSORE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE
JSS HOSPITAL
MYSORE
KARNATAKA
Mysore
KARNATAKA
570004
India |
| Phone |
9538173116 |
| Fax |
|
| Email |
drgirishbk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr GIRISH BK |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
JSS MEDICAL COLLEGE AND HOSPITAL, MYSORE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE
JSS HOSPITAL
MYSORE
KARNATAKA
Mysore
KARNATAKA
570004
India |
| Phone |
9538173116 |
| Fax |
|
| Email |
drgirishbk@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH |
|
|
Primary Sponsor
|
| Name |
JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
JSSAHER, SHIVARATHREESHWARA NAGAR, MYSORE, KARNATAKA - 570015 |
| Type of Sponsor |
Private medical college |
|
|
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 UDIT BATHLA |
JSS MEDICAL COLLEGE AND HOSPITAL |
INTENSIVE CARE UNIT COMPLEX
3RD FLOOR
JSS HOSPITAL
MYSORE
KARNATAKA
Mysore
KARNATAKA |
9501162220
uditbathla1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. PATIENTS AGED MORE THAN 18 YEARS
2. PATIENTS OF EITHER SEX
3. PATIENTS ADMITTED IN INTENSIVE CARE UNIT REQUIRING A CENTRAL VENOUS CATHETER. |
|
| ExclusionCriteria |
| Details |
1. PATIENTS WITH COAGULOPATHY (INR MORE THAN 1.5)
2. PATIENTS WITH INFECTION AT THE SITE OF CANNULATION
3. PATIENTS WITH LESIONS IN THE NECK REGION
4. PATIENTS WHO HAVE UNDERGONE REPEATED INTERNAL JUGULAR VEIN CANNULATION
5. PATIENTS WITH BODY MASS INDEX (BMI) MORE THAN 30
6. PATIENTS NOT WILLING TO PARTICIPATE OR NON-COOPERATIVE PATIENTS |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
WE EXPECT THE SHORT AXIS APPROACH
TO HAVE A BETTER SUCCESS RATE AS COMPARED TO
THE LONG AXIS APPROACH FOR ULTRASOUND GUIDED
RIGHT INTERNAL JUGULAR VEIN CANNULATION IN
ADULT PATIENTS IN INTENSIVE CARE UNIT. |
18 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| COMPARISON OF FIRST PASS SUCCESS RATE AND RATE OF COMPLICATIONS AMONG THE TWO APPROACHES FOR CANNULATION OF RIGHT INTERNAL JUGULAR VEIN IN SINGLE NEEDLE ATTEMPT. |
18 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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
|
N/A |
|
Date of First Enrollment (India)
|
26/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
•THE INVESTIGATOR WILL APPROACH PATIENTS ADMITTED IN JSS HOSPITAL, IN INTENSIVE CARE UNITS REQUIRING A CENTRAL VENOUS CATHETER. •AFTER OBTAINING INFORMED CONSENT, THE PARTICIPANT WILL UNDERGO ULTRASOUND GUIDED RIGHT INTERNAL JUGULAR VEIN CANNULATION USING LOGIQ P6 PRO ULTRASOUND MACHINE BY GE HEALTHCARE. •THE SAMPLE SIZE WILL BE TAKEN AS A TOTAL OF 120 PARTICIPANTS, WITH 60 PARTICIPANTS IN EACH OF THE TWO GROUPS, (MINIMUM OF 53 IN EACH GROUP); CONSIDERING ALPHA ERROR AS 5% AND POWER AS 90% •SUCCESS OF RIGHT INTERNAL JUGULAR VEIN CANNULATION WILL BE CONSIDERED AS INSERTION OF THE CATHETER AND ASPIRATION OF VENOUS BLOOD IN ALL THE PORTS OF THE CATHETER. •DURING THE PROCEDURE, THE INVESTIGATOR WILL OBSERVE THE PROCEDURE AND NOTE THE FOLLOWING: ØFIRST PASS SUCCESS- SUCCESS RATE OF CANNULATION IN SINGLE NEEDLE ATTEMPT. ØNUMBER OF REDIRECTIONS & PRICKS TAKEN ØGUIDE WIRE INSERTION TIME (TIME TAKEN FROM NEEDLE INSERTION TO THE ULTRASOUND CONFIRMATION OF PRESENCE OF GUIDEWIRE IN THE VEIN). ØCATHETER INSERTION TIME (TIME TAKEN FROM ULTRASOUND CONFIRMATION OF PRESENCE OF GUIDEWIRE IN THE VEIN TO THE SUCCESSFUL ASPIRATION OF VENOUS BLOOD FROM ALL THE PORTS OF THE CATHETER). ØCOMPLICATIONS (IF ANY)- POSTERIOR WALL PUNCTURE, ARTERIAL PUNCTURE, PNEUMOTHORAX, HEMOTHORAX, HEMATOMA FORMATION, ARRHYTHMIAS. •VITALS & ELECTROCARDIOGRAPHY MONITORING BEFORE, DURING & AFTER THE PROCEDURE. |