| CTRI Number |
CTRI/2018/01/011517 [Registered on: 23/01/2018] Trial Registered Prospectively |
| Last Modified On: |
30/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Insertion of a device in the arm vein for medication administration utilizing Ultrasound technology . |
|
Scientific Title of Study
|
Ultrasound guided Axillary vein cannulation for intermediate venous access |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SivashanmugamT |
| Designation |
Professor and Head of Department |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Mahatma Gandhi Medical College and Research Institute
Pondicherry Cuddalore ECR, Pillayarkuppam, Puducherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9442505567 |
| Fax |
|
| Email |
drsiva95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Charulatha R |
| Designation |
Assistant Professor |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Department of Anaesthesiology
Second Floor
Hospital BLock
Mahatma Gandhi Medical College and Research Institute
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9894909652 |
| Fax |
|
| Email |
ravindrancharulatha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Charulatha R |
| Designation |
Assistant Professor |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Department of Anaesthesiology
Second Floor
Hospital BLock
Mahatma Gandhi Medical College and Research Institute
Department of Anaesthesiology
Second Floor
Hospital BLock
Mahatma Gandhi Medical College and Research Institute
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9894909652 |
| Fax |
|
| Email |
ravindrancharulatha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Medical College and Research Institute |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Pondicherry Cuddalore ECR, Pillayarkuppam, Puducherry 607402 |
| 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 T Sivashanmugam |
Mahatma Gandhi Medical College and Research Institute |
Pondicherry Cuddalore ECR, Pillayarkuppam, Puducherry 607402
Pondicherry
PONDICHERRY |
9442505567
drsiva95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Medical College and Research institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients requiring central venous access for minimum duration of 15 days, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Ultrasound guided Axillary vein cannulation |
Ultrasound guidance helps us to cannulate the peripheral veins for central venous access and can be maintained without complications in patients requiring intermediate venous access |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for elective surgeries where large fluid shifts ,Central venous pressure monitoring and usage of vasoactive drugs expected
Patients requiring venous access for more than seven days(Total parenteral nutrition, antibiotics,chemotherapy) |
|
| ExclusionCriteria |
| Details |
1) Infection at the site of puncture.
2) Patients with bleeding diathesis.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of catheter days |
Number of catheter days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Anatomy of the axillary vein: depth from the skin, maximum diameter of the vein, relation to the artery and the nerves
2. Side of insertion: right or left
3. Puncture site distance from the distal axillary crease.
4. Number of attempts.
5. Tunneling length.
6. Incidence of procedural complications : arterial puncture / paresthesia
7. Catheter related local infection: pain/ swelling/ redness/ discharge will be assessed every alternate day till removal
|
15 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "72"
Final Enrollment numbers achieved (India)="72" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/01/2018 |
| Date of Study Completion (India) |
31/03/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/03/2020 |
|
Estimated Duration of Trial
|
Years="2"
Months="1"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
1. Nasia safdar, and Dennis G. Maki. Risk of catheter-related blood stream infection with peripherally inserted central venous catheters used in hospitalized patients. CHEST / 128 / 2 / AUGUST, 2005
2. Auffray JP, Martin C, Houvanaeghel M, Rocca B, Chevalier A, Gouin F. Catheterization of the axillary vein in intensive care. Analysis of a series of 151 cases Ann Fr AnesthReanim. 1983;2(4):266-9.
3. Metz RI, Lucking SE, Chaten FC, Williams TM, Mickell JJ Percutaneous catheterization of the axillary vein in infants and children.Pediatrics. 1990 Apr;85(4):531-3.
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Safe and reliable vascular access is an essential component of present day health care. Introduction of ultrasound in vascular access enables the clinician to cannulate more peripheral veins to access the central circulation which are easy to maintain and devoid of central complications. Hence the use of peripherally inserted central venous catheters (PICC) is steadily increasing for intermediate to long term venous access. This study has been designed to evaluate the axillary vein cannulation as a route for central venous access using a conventional (16 gauge 20cm length) single lumen catheter under ultrasound guidance.
|