| CTRI Number |
CTRI/2024/09/073959 [Registered on: 17/09/2024] Trial Registered Prospectively |
| Last Modified On: |
07/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Insertion of central line via supraclavicular subclavian vein in comparison to internal jugular vein
|
|
Scientific Title of Study
|
Comparison of central venous catheterisation through internal jugular vein to subclavian vein (supraclavicular route) |
| 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 Manoj Kumar panwar |
| Designation |
Professor |
| Affiliation |
Department of Anaesthesia, IGMC Shimla |
| Address |
Department of Anaesthesia, IGMC, Ridge Sanjauli Road,Lakkar bazar, Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418086876 |
| Fax |
|
| Email |
drmkpanwar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Charul Rai |
| Designation |
Junior resident |
| Affiliation |
Department of Anaesthesia, IGMC Shimla |
| Address |
Department of Anaesthesia, IGMC, Ridge Sanjauli Road,Lakkar bazar, Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
7018851474 |
| Fax |
|
| Email |
Charulrai444@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manoj kumar Panwar |
| Designation |
Professor |
| Affiliation |
IGMC Shimla |
| Address |
Department of Anaesthesia, IGMC, Ridge Sanjauli Road,Lakkar bazar, Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418086876 |
| Fax |
|
| Email |
drmkpanwar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Himachal Pradesh Government ,city shimla, India , PIN code 171001 |
|
|
Primary Sponsor
|
| Name |
Indra Gandhi Medical College |
| Address |
Ridge Sanjauli road ,Lakkar bazar,Shimla,Himachal Pradesh-171001 |
| 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 Charul Rai |
Indira Gandhi Medical College, Shimla |
Department of Anaesthesia
Ot complex1234
Shimla
HIMACHAL PRADESH |
7018851474
charulrai444@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Indira Gandhi Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R99||Ill-defined and unknown cause of mortality, , (2) ICD-10 Condition: O||Medical and Surgical, , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
USG guided central venous catheterisation through internal jugular vein |
Central venous catheterisation in chronically ill patients, patients undergoing major surgery will be done ultrasonographically through internal jugular vein |
| Comparator Agent |
USG guided central venous catheterisation through subclavian vein |
Central venous catheterisation in chronically ill patients, patients undergoing major surgery will be done ultrasonographically through Supraclavicular subclavian vein |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patient needing central venous catheterisation for any indication |
|
| ExclusionCriteria |
| Details |
Infection at puncture site, deranged coagulation profile, contralateral pneumothorax, cervical spine trauma , pt on warfarin or heparin less than 12 hours |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of attempts with ease of visibility between subclavian vein and internal jugular vein |
10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find complications ( pneumothorax, hemothorax, thrombophlebitis) |
48hours |
|
|
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)
|
23/09/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
We hypothesises that supraclavicular approach to SCV is more promising with less complications and easier to insert as compared to IJV insertion. Hence, We have planned a prospective, comparative, randomized study to compare CVC insertion through IJV vs SCV via supraclavicular route under real time USG guidance
|