| CTRI Number |
CTRI/2025/10/096680 [Registered on: 30/10/2025] Trial Registered Prospectively |
| Last Modified On: |
27/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Procedure trial] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of lateral oblique view in axillary vs internal jugular vein cannulation under ultrasound guidance |
|
Scientific Title of Study
|
Ultrasound-guided Oblique View of Axillary Vein canulation versus Oblique View of Internal Jugular Vein Canulation: A Randomized 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 Sangeeta Sahoo |
| Designation |
Additional Professor Department of Trauma and Emergency |
| Affiliation |
Aiims Bhubaneswar |
| Address |
Room number 9
Third floor
Trauma centre
Aiims Bhubaneswar
AIIMS BHUBANESWAR,SIJUA,PATRAPADA
Khordha
ORISSA
751019
India |
| Phone |
9556547655 |
| Fax |
|
| Email |
drsangeeta.asth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sangeeta Sahoo |
| Designation |
Additional Professor Department of Trauma and Emergency |
| Affiliation |
Aiims Bhubaneswar |
| Address |
Room number 9
Third floor
Trauma centre
Aiims Bhubaneswar
AIIMS BHUBANESWAR,SIJUA,PATRAPADA
Khordha
ORISSA
751019
India |
| Phone |
9556547655 |
| Fax |
|
| Email |
drsangeeta.asth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pearl S Konikkara |
| Designation |
Academic junior resident Department of trauma and emergency |
| Affiliation |
Aiims Bhubaneswar |
| Address |
Room 312 Nawah 9 arcadia behind Aiims Bhubanaeswar
Khordha
ORISSA
751019
India |
| Phone |
9495657505 |
| Fax |
|
| Email |
pearlsoji@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Bhubaneswar Odisha India
751019 |
|
|
Primary Sponsor
|
| Name |
Aiims Bhubaneswar |
| Address |
AIIMS BHUBANESWAR SIJUA PATRAPADA
Odisha 751019 |
| Type of Sponsor |
Government 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 Sangeeta Saho |
All India Institute of Medical Sciences Bhubaneswar |
Department of Trauma and Emergency
Khordha
ORISSA |
9556547655
drsangeeta.asth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe for Faculty Research AIIMS Bhubaneswar |
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 |
Axillary vein lateral oblique view |
Central venous cannulation performed under ultrasound guidance using the oblique view of the axillary vein. If the guidewire will not be inserted in 15 min in the assigned approach or will be inserted in another approach, we will define it as an unsuccessful catheterization. |
| Comparator Agent |
Internal jugular vein lateral oblique view |
Central venous cannulation performed under ultrasound guidance using the oblique view of the internal jugular vein. If the guidewire will not be inserted in 15 min in the assigned approach or will be inserted in another approach, we will define it as an unsuccessful catheterization. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patients having indication for central venous cannulation
Age 18 to 85 years
Intubated patients
|
|
| ExclusionCriteria |
| Details |
Skin infection and previous surgery at the catheterization site
INR more than 2 and platelet count less than 50000
Clavicle or proximal ribs fracture in trauma patients
Pregnancy
Moderate to end stage chronic kidney disease
Severe hypoxemia or apical bullous lung disease
Obese patients BMI more than 30 kg per m²
Refusal to participate
Suspected coagulation disorders
Congenital malformations of neck
Thrombosis of axillary vein or internal jugular vein
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Performing time for ultrasound-guided cannulation in oblique view of axillary vein versus oblique view of internal jugular vein. Performing time is defined as the time duration from puncture of skin to visualization of the guidewire in vein.
|
0 , 5 , 15 , 30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| First attempt success rate |
0 , 1 , 5 minutes |
| Incidence of complications such as arterial puncture, hematoma, pneumothorax, or catheter misplacement. |
0, 1 hour, 2 hours , 4 hours |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
25/11/2025 |
| 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 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
|
This randomized controlled trial will compare the ultrasound guided oblique view of axillary vein cannulation with the ultrasound guided oblique view of internal jugular vein cannulation in adult patients who require central venous access in the emergency department of AIIMS Bhubaneswar. A total of 80 patients will be enrolled and randomly assigned to either axillary or internal jugular vein groups. The study will assess the performing time, first attempt success rate, and complications such as arterial puncture, hematoma, or pneumothorax. All procedures will be carried out under strict aseptic precautions by trained emergency medicine residents. The study aims to determine which ultrasound guided approach provides faster, safer, and more effective central venous cannulation in emergency settings. |