| CTRI Number |
CTRI/2024/04/065914 [Registered on: 18/04/2024] Trial Registered Prospectively |
| Last Modified On: |
16/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [CENTRAL LINE INSERTION TECHNIQUE] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ultrasound se Seethi aur ulti awastha me central line daalne ki tulna ka adhyaan karna
|
|
Scientific Title of Study
|
Comparison of first attempt success rate of ultrasound-
guided internal jugular vein cannulation in supine vs prone position: A
prospective 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 Aathira Surendran |
| Designation |
Junior Resident |
| Affiliation |
Junior Resident, anesthesia, AIIMS JODHPUR |
| Address |
Department of Anaesthesiology and Critical Care, AIIMS Jodhpur, Basni Industrial area Phase 2, Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7727897827 |
| Fax |
|
| Email |
aathiras39@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankur Sharma |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care, AIIMS Jodhpur, Basni Industrial area Phase 2, Jodhpur, Rajasthan
Department of Anaesthesiology and Critical Care, AIIMS Jodhpur, Basni Industrial area Phase 2, Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9654045653 |
| Fax |
|
| Email |
ankuranaesthesia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankur Sharma |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care, AIIMS Jodhpur, Basni Industrial area Phase 2, Jodhpur, Rajasthan
Department of Anaesthesiology and Critical Care, AIIMS Jodhpur, Basni Industrial area Phase 2, Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9654045653 |
| Fax |
|
| Email |
ankuranaesthesia@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences (AIIMS), Jodhpur |
|
|
Primary Sponsor
|
| Name |
AIIMS Jodhpur |
| Address |
Basni Industrial area Phase 2, Jodhpur, Rajasthan
Pin : 342005 |
| 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 Ankur Sharma |
AIIMS Jodhpur |
Department of Anaesthesiology and Critical Care, AIIMS Jodhpur, Basni Industrial area Phase 2, Jodhpur, Rajasthan
Jodhpur
RAJASTHAN |
9654045653
ankuranaesthesia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL, ETHICAL COMMITTEE, AIIMS JODHPUR |
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 |
prone position IJV cannulation |
US guided IJV cannulation will be performed in prone position |
| Comparator Agent |
supine IJV cannulation |
US guided IJV cannulation will be performed in Supine position |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients requiring IJV cannulation either in OT /ICU
1. Aged ≥18 years
2. Belonging to ASA Status 1-3
3. Either scheduled for surgery in prone position requiring CVC or as pt with severe ARDS required prone
position in ICU |
|
| ExclusionCriteria |
| Details |
1. Patients with previous surgery at the site of insertion
2. Infection at the site of insertion
3. Patients with coagulopathy or on anticoagulation therapy.
4. IJV could not be visualized or appear thrombosed during initial screening |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the first attempt success rate of IJV cannulation in supine and prone
position |
In OT during study period
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the access time of IJV cannulation in the two positions.
To compare the guide wire insertion time of IJV cannulation in the two positions.
To compare the catheterisation time of IJV cannulation in the two positions.
To compare the number of attempts taken for IJV cannulation in the two
positions.
To compare the total success rate of IJV cannulation in the two positions.
To compare the complications of IJV cannulation in the two positions. |
In OT during study period |
|
|
Target Sample Size
|
Total Sample Size="192"
Sample Size from India="192"
Final Enrollment numbers achieved (Total)= "192"
Final Enrollment numbers achieved (India)="192" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2024 |
| Date of Study Completion (India) |
01/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
A central venous catheter (CVC) is an indwelling vascular catheter with a tip that lies within
the proximal third of the superior vena cava, the right atrium, or the inferior vena cava, used for major surgeries, CVP measurement and difficult peripheral venous cannulation. Usually CVC is inserted in supine position. In the setting of COVID pandemic, many patients falling ill with acute respiratory distress syndrome eventually require prone positioning for gas exchange. However, when a patient cannot tolerate supine position and the need for central venous access is urgent, catheter placement may be considered with the patient in prone position. Another instance where use of IJV cannulation in prone position comes into picture is in the Operating Room setting when the patient is in prone position and there is massive blood loss and patient needs urgent CVC placement. In this trial, the first attempt success rate (primary outcome) of IJV cannulation will be compared in supine versus prone position. Other outcomes like access time, guide wire insertion time, catheterization time, success and failure of IJV cannulation in both the positions will be assessed. |