| CTRI Number |
CTRI/2023/05/052615 [Registered on: 15/05/2023] Trial Registered Prospectively |
| Last Modified On: |
10/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of neck vein and shoulder vein cannulation under ultrasound guidance in adult patients |
|
Scientific Title of Study
|
Comparison of Ultrasound guided Infraclavicular Axillary Vein versus Internal
Jugular Vein cannulation in adult critically ill patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rahul Sharma |
| Designation |
Post graduate resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia, Main OT block, VMMC and Safdarjung Hospital, Ansari Nagar East, New Delhi
South
DELHI
110029
India |
| Phone |
9958659765 |
| Fax |
|
| Email |
rahulsharmavmmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Kumar |
| Designation |
Associate Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia, Main OT block, VMMC and Safdarjung Hospital, Ansari Nagar East, New Delhi
South
DELHI
110029
India |
| Phone |
9871372430 |
| Fax |
|
| Email |
ajayk17@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Kumar |
| Designation |
Associate Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia, Main OT block, VMMC and Safdarjung Hospital, Ansari Nagar East, New Delhi
South
DELHI
110029
India |
| Phone |
9871372430 |
| Fax |
|
| Email |
ajayk17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia, Main OT block, VMMC and Safdarjung Hospital, Ansari Nagar East, New Delhi |
| 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 Rahul Sharma |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department of Anaesthesia, Main OT block, VMMC and Safdarjung
Hospital, Ansari Nagar East
South
DELHI |
9958659765
rahulsharmavmmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
Comparison of Ultrasound guided Infraclavicular Axillary Vein versus Internal
Jugular Vein cannulation in adult critically ill patients. |
Total procedural time - Total time required from placement of the USG probe to the completion of final dressing. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult critically ill patients admitted in ICU requiring central venous cannulation |
|
| ExclusionCriteria |
| Details |
1. Body Mass Index >30kg/m2 .
2. Contraindications to the Central Venous Catheterization insertion (coagulopathies, on anticoagulants, thrombosis, local site infection).
3. Raised Intracranial Pressure.
4. Patients with arrhythmia or underlying lung disease.
5. Vertical depth of Axillary Vein >4cm from skin.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare ultrasound guided infraclavicular axillary vein versus internal jugular vein
cannulation in adult critically ill patients using total procedural time |
Total time required from placement of the USG probe to the completion of final dressing.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Access time
2. Guidewire time
3. Skin to vein depth
4. Needle attempts
5. Complications |
Access time - Time required from first skin puncture to the aspiration of blood from vein through the needle.
Guidewire time - From needle puncture to smooth passage of guidewire till 20 cm
Skin to vein depth - Vertical depth of the respective vein from skin
Needle attempts - Every time the needle enters the skin after exiting will be described as an attempt
Complications: Arrythmias, Arterial puncture, Hematoma, Pneumothorax, Misplaced guidewire, Site conversion. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
18/05/2023 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomised comparative interventional study
comparing the efficacy of ultrasound guided infraclavicular axillary vein
versus internal jugular vein cannulation in 60 adult critically ill patients using
total procedural time as primary outcome. The two approaches will be compared
in terms of total procedural time, access time, guidewire time, skin to vein depth,
number of attempts and complication rate of each approach. A post procedure X
ray will be done to rule out complications associated with the procedure. |