| CTRI Number |
CTRI/2024/07/069748 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
28/06/2024 |
| 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 supraclavicular and infraclavicular approaches of Ultrasound guided subclavian vein cannulation in patients posted for elective surgeries. |
|
Scientific Title of Study
|
To compare supraclavicular and infraclavicular approaches of subclavian vein cannulation under Ultrasound guidance : a randomised clinical 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 |
Y Sudha Devi |
| Designation |
Jr.Resident |
| Affiliation |
Rangaraya Medical College, Kakinada |
| Address |
Department of Anaesthesiology,,
Government General Hospital,
Kakinada
East Godavari
ANDHRA PRADESH
533001
India |
| Phone |
9248862244 |
| Fax |
|
| Email |
sudhadeviyaramati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. G. Prasanna Kumar |
| Designation |
Professor |
| Affiliation |
Rangaraya Medical College, Kakinada |
| Address |
Department of Anaesthesiology,,
Government General Hospital,
Kakinada
East Godavari
ANDHRA PRADESH
533001
India |
| Phone |
9848189689 |
| Fax |
|
| Email |
Prince91prem@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KVindhya |
| Designation |
Professor |
| Affiliation |
Rangaraya Medical College, Kakinada |
| Address |
Department of Anaesthesiology,,
Government General Hospital,
Kakinada
ANDHRA PRADESH
533001
India |
| Phone |
7702479295 |
| Fax |
|
| Email |
vindhyakakula@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Rangaraya Medical College, Kakinada, East Godavari - 533001 |
|
|
Primary Sponsor
|
| Name |
Y Sudha Devi |
| Address |
Department of Anaesthesiology, Rangaraya Medical College, Kakinada |
| Type of Sponsor |
Other [Self] |
|
|
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 Y Sudha Devi |
Government General Hospital, Kakinada |
Surgery Theatre, Orthopedics Theatre and Neurosurgery Theatre, Department of Anaesthesiolog, Rangaraya Medical College, Kakinada
East Godavari
ANDHRA PRADESH |
9248862244
sudhadeviyaramati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rangaraya Medical College Institutional Ethics Committee Cell |
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 |
Subclavian Vein Cannulation |
Ultrasound guided Infraclavicular approach of Subclavian Vein Cannulation unilaterally within 15 mins before surgical incision |
| Intervention |
Subclavian Vein Cannulation |
Ultrasound guided Supraclavicular Approach of Subclavian Vein Cannulation unilaterally within 15mins before surgical incision |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of American Society of Anaesthesiologists (ASA) physical status I/II/III/IV
2. Aged between 18 and 60 years.
3. Body mass index of 18–35kg/m2. |
|
| ExclusionCriteria |
| Details |
Patients having an 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 and patients not giving consent for the study. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean puncture time |
10 secs
20 secs
40 secs
60 secs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Catheter insertion time |
0mins
1 min
2 mins
3 mins |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
24/08/2024 |
| 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 Applicable |
| 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
|
Subclavian vein cannulation is essential procedure in elective surgeries. Ultrasound guidance leads to less complications like pneumothorax and increases accuracy in procedure.
My study aimed at comparison between supraclavicular and infraclavicular approaches in their mean puncture time and catheter insertion time for Subclavian Vein Cannulation. |