| CTRI Number |
CTRI/2022/07/044253 [Registered on: 22/07/2022] Trial Registered Prospectively |
| Last Modified On: |
21/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to compare two methods,above and below the collar bone in neck to gain a venous access of a large central vein called subclavian vein in neck with the help of ultrasound scan. |
|
Scientific Title of Study
|
A prospective Randomised clinical study to compare supraclavicular versus infraclavicular approach of subclavian vein cannulation under ultrasound guidance |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr A Ilakya |
| Designation |
Third year post graduate resident |
| Affiliation |
Melmaruvathur Adhiparasakthi institute of Medical Sciences and Research |
| Address |
Department of Anesthesiology,Melmaruvathur Adhiparasakthi
institute of Medical Sciences and Research, Melmaruvathur,Kancheepuram District,Tamilnadu 603319
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
9176738810 |
| Fax |
|
| Email |
ilakya16894@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T Swarnalingam |
| Designation |
Professor |
| Affiliation |
Melmaruvathur Adhiparasakthi institute of Medical Sciences and Research |
| Address |
Department of Anaesthesiology,Melmaruvathur Adhiparasakthi
institute of Medical Sciences and
Research,Melmaruvathur,kancheepuram District,Tamilnadu 603319
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
8144008182 |
| Fax |
|
| Email |
lingamjks@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Ilakya |
| Designation |
Third year post graduate resident |
| Affiliation |
Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesiology,Melmaruvathur Adhiparasakthi
institute of Medical Sciences and
Research,Melmaruvathur,kancheepuram District,Tamilnadu 603319
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
9176738810 |
| Fax |
|
| Email |
ilakya16894@gmail.com |
|
|
Source of Monetary or Material Support
|
| Melmaruvathur Adhiparasakthi institute of Medical Sciences and
Research,Melmaruvathur,kancheepuram District,Tamilnadu,India 603319 |
|
|
Primary Sponsor
|
| Name |
Melmaruvathur Adhiparasakthi institute of Medical Sciences and Research |
| Address |
Melmaruvathur,kancheepuram District,Tamilnadu,India 603319 |
| 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 Ilakya |
Melmaruvathur Adhiparasakthi institute of Medical Sciences and Research |
Department of Anaesthesiology and critical care,Intensive care unit,C zone,First
floor,Hospital block,kan
cheepuram,Tamil Nadu
Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU |
9176738810
ilakya16894@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Com mittee,Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, (2) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, (3) ICD-10 Condition: V00-Y99||External causes of morbidity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Infraclavicular approach of subclavian vein cannulation |
To compare the time taken for successful subclavian vein cannulation in infraclavicular approach under Ultrasound guidance |
| Intervention |
Supraclavicular approach of subclavian vein cannulation |
To compare the time taken for successful subclavian vein cannulation in supraclavicular approach under Ultrasound guidance |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-65 years
Both genders
American Society of anaesthesiologists(ASA) physical status I,II,III and IV
Critically ill ICU patients for whom CVC is indicated
BMI < 30.
|
|
| ExclusionCriteria |
| Details |
Infection At The Puncture Site,
Deranged Coagulation Profile,
Pneumothorax,
Uncontrolled Hypertension,
Pulmonary Disease,
Severe Cardiac Disease,
Distorted Anatomy of the Neck Or Clavicle,
Previous Central Line Insertions, Or
Not Giving Consent
|
|
|
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 time taken for successful subclavian vein cannulation (time taken from placement of ultrasound probe over the skin to aspiration of blood from the catheter) between supraclavicular versus infraclavicular approach under ultrasound guidance |
To compare the time taken for successful subclavian vein cannulation (time taken from placement of ultrasound probe over the skin to aspiration of blood from the catheter) between supraclavicular versus infraclavicular approach under ultrasound guidance |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time taken for puncture of vessel (time taken from placement of ultrasound probe over the skin to aspiration of blood from subclavian vein)
Incidence of complications
No of attempts and redirection of the needle
Ease of insertion – (graded as excellent, good, bad)
Calculation SCVCI (Subclavian central venous catheter insertion )score:
Components of SCVCI score- no of attempts, time taken for cannulation, complications and procedure accomplished successfully/failure, ease of insertion.
|
2minutes,3minutes and more than 3minutes |
|
|
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)
|
25/07/2022 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL,will be published after completion of study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a prospective randomised study to compare the primary outcome which is the
time taken for successful subclavian
vein cannulation between supraclavicular versus infraclavicular
approach under ultrasound guidance in ICU patients of Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research. secondary outcome is •Time
taken for puncture of vessel (time taken from placement of ultrasound probe
over the skin to aspiration of blood from subclavian
vein)
•Incidence
of complications
•No
of attempts and redirection of the needle
•Ease
of insertion – (graded as excellent, good, bad)
•Calculation
SCVCI (Subclavian
central venous catheter insertion )score:
|