| CTRI Number |
CTRI/2019/09/021276 [Registered on: 17/09/2019] Trial Registered Prospectively |
| Last Modified On: |
13/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of USG guided two ways for Neck vein canulation in Heart patients |
|
Scientific Title of Study
|
A comparitive study of USG guided short axis verses oblique axis approch for internal jugular vein canulation in cardiac surgical patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Alok Kumar Bharti |
| Designation |
Assistant Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES,DEPARTMENT OF ANAESTHESIA, FIRST FLOOR,PATNA
Patna
BIHAR
800014
India |
| Phone |
9307645596 |
| Fax |
|
| Email |
alok.bharti48@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Alok Kumar Bharti |
| Designation |
Assistant Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES , DEPARTMENT OF ANAESTHESIA, FIRST FLOOR, PATNA
Patna
BIHAR
800014
India |
| Phone |
9307645596 |
| Fax |
|
| Email |
alok.bharti48@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Alok Kumar Bharti |
| Designation |
Assistant Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
IGIMS, DEPARTMENT OF ANAESTHESIOLOGY , FIRST FLOOR PATNA
Patna
BIHAR
800014
India |
| Phone |
9307645596 |
| Fax |
|
| Email |
alok.bharti48@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alok Kumar Bharti , Assistant Professor , Department of Anaesthesia ,Indira Gandhi Institute of Medical Sciences,Patna |
|
|
Primary Sponsor
|
| Name |
Alok Kumar Bharti |
| Address |
Assistant Professor, Department of Anaesthesia, Indira Gandhi Institute of Medical Sciences , Seikhpura, Patna |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Kunal Kumar Singh |
Indira Gandhi Institute of Medical Sciences , Seikhpura , Patna |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Alok Kumar Bharti |
Indira Gandhi Institute of Medical Sciences |
Department of Anaesthesiology,First Floor,Seikhpura
Patna
BIHAR |
9307645596
alok.bharti48@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IGIMS ETHICAL COMMITTEE |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
USG guided short axis and oblique axis approch for IJV canulation . |
One group will receive IJV canulation by short axis apporch of USG and other group will receive IJV canulation by oblique axis approch of USG / |
| Intervention |
USG guided short axis and oblique axis approch for IJV canulation . |
One group will receive IJV canulation by short axis approch of USG and other group will receive IJV canulation by oblique axis approch of USG . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Elective cardiopulmonary bypass |
|
| ExclusionCriteria |
| Details |
Patient Refusal , coagulopathy and Infection at canulation site |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
First attempt successful
canulation and Catherisation time |
12 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complications related to procedure |
less than 30 minute |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
28/09/2019 |
| Date of Study Completion (India) |
22/09/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Our study is a randomized, double blinded,parellel group single centric trial comparing the Ultrasound guided short axis verses oblique axis approch for internal jugular vein canulation in140 Cardiac surgical patients over a period of 12 month.The primary outcome will be First pass needle time and catheterisation time. The Secondary outcome will canulation related side effects. |