| CTRI Number |
CTRI/2024/02/062570 [Registered on: 13/02/2024] Trial Registered Prospectively |
| Last Modified On: |
09/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To access the stability of central venous catheter by doing tunneling |
|
Scientific Title of Study
|
Does tunneling the central venous catheter improve stability? A prospective randomised study |
| 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 Chandipriya Singh |
| Designation |
Postgraduate |
| Affiliation |
Dr. DY Patil medial college, hospital, research center , Pimpri pune |
| Address |
Department of Anaesthesiology , 5th floor, room number 5
Dr. Dy Patil medical college, hospital and research
center , Dy Patil vidyapeeth Pimpri Pune
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9849564821 |
| Fax |
|
| Email |
cpriya2612@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Vipul k Sharma |
| Designation |
Professor |
| Affiliation |
Dr. DY Patil medial college, hospital, research center , Pimpri pune |
| Address |
Department of anaesthesiology, 5th floor, high tech building room number 5 , Dr. DY Patil medical college, research centre, hospital , dypatil vidyapeeth , pimpri pune
Pune
MAHARASHTRA
411014
India |
| Phone |
9849564821 |
| Fax |
|
| Email |
priya.twinkle126@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandipriya Singh |
| Designation |
junior resident |
| Affiliation |
Dr. DY Patil medial college, hospital, research center , Pimpri pune |
| Address |
Department of anaesthesiology . Dr. Dy Patil medical college, hospital and research center , Dy Patil
vidyapeeth Pimpri Pune
Pune
MAHARASHTRA
411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9849564821 |
| Fax |
|
| Email |
cpriya2612@gmail.com |
|
|
Source of Monetary or Material Support
|
| 5th floor hightech building,Dr. Dy Patil Medical College Research Center Hospital Pimpri Pune |
|
|
Primary Sponsor
|
| Name |
Dr Chandipriya Singh |
| Address |
Old girls hostel . Dr. Dy Patil medical and research center , Dy Patil
vidyapeeth Pimpri Pune
Pune
MAHARASHTRA
411018 |
| 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 Chandi priya singh |
Dr,dy patil medical college |
High tech building , 5th floor , high tech ot complex
Dr,dy patil medical college,dy patil vidyapeeth,pimpri,pune
Pune
MAHARASHTRA |
9849564821
cpriya2612@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONAL ETHICS SUB COMMITEE Dr.D.Y.PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I228||Subsequent ST elevation (STEMI) myocardial infarction of other sites, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Non tunneling of central venous catheter |
Fixing the catheter with external fixator device and checking the stability and parameters till day 7 |
| Intervention |
Tunneling the central venous catheter |
Tunneling central line in patients on day of surgery and checking all parameters till day 7 |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Asa 2 and asa 3 patients with ejection fraction more Than 45% |
|
| ExclusionCriteria |
| Details |
Unwilling patients
Ejection fraction less than 45%
Thrombosed internal jugular vein
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Stability of central venous Catheter
Less scar
less chance of infection while handling
Cosmetically better
Less source of infection |
day 3 to day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Level of Catheter Above Or below the svc ra Junction
Rright Main Bronchus
|
Day 0 to day 7 |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
19/02/2024 |
| 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="0"
Months="6"
Days="10" |
|
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
|
study helps in ruling out the stability of central venous catheter when tunelled and to ruleout infection control while handling the central line |