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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06155045
Other study ID # 95/2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date December 31, 2021

Study information

Verified date December 2023
Source Government Medical College Kottayam
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this study is to compare the efficacy of a new harvesting technique for an arterial conduit(LIMA - Left Internal Mammary artery) in patients undergoing Coronary artery bypass grafting. The researcher will compare the 1. Time taken to harvest the artery 2. Flow of blood between the two techniques


Description:

Following consultation to our department, after a detailed history and clinical examination,patients with CAD, being planned for CABG, will be subjected to a detailed pre-op Echocardiogram and coronary angiogram. After necessary pre-op assessment, patient will be taken up for the surgery. Invasive monitoring will be done. Following dissection of LIMA by the above mentioned technique, flow of blood from the harvested LIMA, for one whole minute is noted. The operative time required for the dissection of LIMA will be noted and entered. The data between the two techniques will be compared statistically.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: 1. Elective CABG 2. Hemodynamically stable CAD patients Exclusion Criteria: 1. Re-operation, previous sternotomy (where LIMA is already dissected) 2. concomitant valve operation, ventricular aneurysm resection 3. other additional major cardiac procedures 4. Patients with chronic obstructive pulmonary disease

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Modified Carbo-dissection Technique
This technique comes the C02 blower with electrocautery. Thereby, producing vasodilatation due to the gas and dissection aided by the electrocautery.
Conventional Arm
This technique uses only the electrocautery as conventional model

Locations

Country Name City State
India Government Medical College Kottayam Kottayam Kerala

Sponsors (1)

Lead Sponsor Collaborator
Government Medical College Kottayam

Country where clinical trial is conducted

India, 

References & Publications (3)

Gilbert S, Singh D, Sivakumar MK. Modified carbodissection: A new technique for harvesting the internal mammary artery. Multimed Man Cardiothorac Surg. 2017 Oct 29;2017. doi: 10.1510/mmcts.2017.018. — View Citation

Lee ME. Carbodissection of the internal thoracic artery pedicle. Ann Thorac Surg. 1988 Oct;46(4):470-1. doi: 10.1016/s0003-4975(10)64671-1. — View Citation

Ozkan M, Koramaz I, Ulus AT, Tavil Y, Filizlioglu H, Baykan EC, Eryilmaz S, Inan B, Katircioglu SF, Ozyurda U. Effect of carbon dioxide insufflation on free internal thoracic artery flows: is it a vasodilator? J Thorac Cardiovasc Surg. 2004 Sep;128(3):354-6. doi: 10.1016/j.jtcvs.2003.11.006. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Operative time Time taken to perform the harvesting of the LIMA 10-20 min
Primary Blood flow/min Post dividing of the LIMA: blood from the LIMA is measured for 1 min 1 min
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