| CTRI Number |
CTRI/2026/01/100043 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
31/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
How safe and useful is putting a tube into the neck vein (external jugular vein) of very sick patients in the ICU: A study watching what happens in real life. |
|
Scientific Title of Study
|
Safety profile and Clinical Utility of External jugular vein cannulation in ICU Patients: A prospective Observational Study. |
| 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 Praveen B K |
| Designation |
Senior Resident |
| Affiliation |
St JOHNS MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of critical care medicine, St johns medical college and hospital, Koramangala, Bengaluru, 560034
Bangalore KARNATAKA 560034 India |
| Phone |
7022642652 |
| Fax |
|
| Email |
praveenbk93@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Carol D’Silva |
| Designation |
Associate Professor |
| Affiliation |
St JOHNS MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of critical care medicine, St johns medical college and hospital, Koramangala, Bengaluru, 560034
Bangalore KARNATAKA 560034 India |
| Phone |
7022642652 |
| Fax |
|
| Email |
carol.ds@ stjohns.in |
|
Details of Contact Person Public Query
|
| Name |
Dr PRAVEEN B K |
| Designation |
Senior Resident |
| Affiliation |
St JOHNS MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of critical care medicine, St johns medical college and hospital, Koramangala, Bengaluru, 560034
Bangalore KARNATAKA 560034 India |
| Phone |
7022642652 |
| Fax |
|
| Email |
praveenbk93@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
St johns medical college and hospital |
| Address |
Department of critical care medicine, St johns medical college and hospital, Koramangala, Bengaluru, 560034 |
| 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 PRAVEEN B K |
St johns medical college and hospital |
MICU, DEPARTMENT OF CRITICAL CARE, ST JOHNS MEDICAL COLLEGE AND HOSPITAL, KORAMANGALA, BENGALURU - 560034 Bangalore KARNATAKA |
7022642652
praveenbk93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, SJMCH |
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 |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Adults more than or equal to 18 years admitted to MICU requiring peripheral venous access through EJV. |
|
| ExclusionCriteria |
| Details |
1. Presence of burns, infected wounds, or surgery of Neck at the site of EJV cannulation.
2. EJV Cannulation performed outside ICU
3. EJV cannula disconnected outside ICU
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the complications following EJV cannulation in ICU patients
• To determine the indications of EJV cannulation in ICU patients
|
At baseline, every 24 hours till EJV is removed, 48 hours after removal |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess CVC free days.
2. To assess patient comfort with EJV cannula in situ.
|
At baseline, every 24 hours till EJV is removed, 48 hours after removal |
|
|
Target Sample Size
|
Total Sample Size="164" Sample Size from India="164"
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)
|
27/02/2026 |
| 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
|
External jugular vein (EJV) cannulation is frequently used in intensive care units (ICUs) as an alternative vascular access in patients with difficult peripheral venous cannulation or when short-term administration of vasopressors, blood products, or hyperosmolar/vesicant drugs is required. Compared to central venous catheter (CVC) insertion, EJV cannulation is perceived to be less invasive and may avoid complications such as pneumothorax, arterial puncture, deep vein thrombosis, and central line–associated bloodstream infections (CLABSI). However, there is limited prospective data on the complication profile, optimal duration, and clinical outcomes of EJV cannulation in critically ill adults. This prospective observational cohort study will be conducted over one year in the ICU of St. John’s Medical College Hospital. Adult ICU patients requiring EJV cannulation as per standard ICU protocol will be enrolled. EJV cannulation will be performed using landmark-guided or ultrasound-guided techniques under aseptic precautions by trained ICU personnel. Patients will be followed from the time of cannulation until 48 hours after catheter removal. The study aims to determine the indications and complications associated with EJV cannulation. Secondary outcomes include assessment of CVC-free days and patient comfort with the EJV cannula in situ. Data on demographics, indication for cannulation, procedural details, duration of cannula placement, daily local and systemic complications, microbiological outcomes, patient comfort scores, and need for subsequent CVC insertion will be collected. Ultrasound evaluation will be performed after catheter removal to detect delayed complications such as thrombosis. The findings of this study may help define the safety profile understanding, optimal dwell time, and clinical utility of EJV cannulation in ICU settings, particularly in resource-limited environments. |