| CTRI Number |
CTRI/2024/02/063261 [Registered on: 28/02/2024] Trial Registered Prospectively |
| Last Modified On: |
05/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the flow difference between two tubes during supply of heart stopping solution |
|
Scientific Title of Study
|
Comparison of pressure difference between PVC RCSP cannula and silicone coronary artery cannula during retrograde cardioplegia delivery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shriya |
| Designation |
2nd year Masters student |
| Affiliation |
Manipal College of Health Professions, MAHE |
| Address |
Department of Perfusion Technology, Manipal College of Health Professions, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9449583153 |
| Fax |
|
| Email |
shriyaurala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sainath |
| Designation |
Assistant Professor and Program Coordinator |
| Affiliation |
Manipal College of Health Professions, MAHE |
| Address |
Room No 413, 4th floor, Perfusion Technology Program, Manipal College of Health Professions, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9060172211 |
| Fax |
|
| Email |
sai.sainath96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sainath |
| Designation |
Assistant Professor and Program Coordinator |
| Affiliation |
Manipal College of Health Professions, MAHE |
| Address |
Room No 413, 4th floor, Perfusion Technology Program, Manipal College of Health Professions, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9060172211 |
| Fax |
|
| Email |
sai.sainath96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Cardiovascular and Thoracic Surgery, Room No. 32, Third floor, OPD building, Kasturba Hospital, Manipal |
|
|
Primary Sponsor
|
| Name |
Department of Cardiovascular and Thoracic Surgery |
| Address |
Room No 32, 3rd floor OPD building, Kasturba Hospital, Manipal |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Guruprasad Rai D |
Kasturba Hospital |
Department of Cardiovascular and Thoracic surgery,Room No. 32, 3rd floor, OPD building, Kasturba Hospital, Manipal, 576104
Udupi
KARNATAKA |
9886730726
drgururai13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Katurba hospital, Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I083||Combined rheumatic disorders of mitral, aortic and tricuspid valves, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing cardiac surgery using Cardiopulmonary Bypass |
|
| ExclusionCriteria |
| Details |
Emergency Cardiac surgeries |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparing the pressure difference between PVC RCSP cannula and silicone coronary artery cannula during retrograde cardioplegia delivery at different dose interval |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
15/03/2024 |
| 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="2"
Months="0"
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
|
This study is done to compare the pressure difference between PVC RCSP cannula and silicone coronary artery cannula and to determine if silicone coronary artery cannula is as compatible as the PVC RCSP cannula. This proposed study can open new avenue for the potential use of silicone coronary artery cannula in delivering retrograde cardioplegia. |