Comparing a New Technique of Combining Carbon-dioxide With Electrocautery With Usual Technique of Stand-alone Electrocautery for Taking Down Left Internal Mammary Artery for Coronary Artery Bypass(CABG) (CABG)

A Comparative Study Between Conventional & Modified Carbo-dissection Techniques for LIMA Harvesting in CABG Patients

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Coronary Artery Disease With Myocardial Infarction
• Intervention / Treatment: Procedure: Modified Carbo-dissection Technique; Procedure: Conventional Arm

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Kerala
    • Kottayam, Kerala, India, 686008
      • Government Medical College Kottayam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modified Carbo-dissection technique; The carbo-dissection technique is performed using an improvised instrument that combines an electrocautery pencil (ValleylabTM Force FX electrocautery Pencil, Covidien, USA) with a CO2 mister blower (PerfX® Heart Lung pack Blower/Mister Kit, B L Lifesciences, Noida, India) and the instruments are fixed together using silk ties.The electrocautery is used in the coagulation mode at a setting of 10 to 15. The C02 flow is set at 2 to 3 litres/minute. Saline flow is adjusted to a level that does not hinder the effective coagulation but still prevents drying and desiccation of the tissues. Following the dissection of LIMA by the techniques mentioned above, blood flow from the harvested LIMA for one whole minute was noted(1 min post division of LIMA). The operative time required for LIMA dissection was also noted and entered. Patient's s demographic data were also collected and entered.	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.
Active Comparator: Conventional Arm; The conventional technique is performed using an electrocautery pencil (ValleylabTM Force FX electrocautery Pencil, Covidien, USA). The electrocautery is used in the coagulation mode at a setting of 10 to 15. Following the dissection of LIMA, blood flow from the harvested LIMA for one whole minute was noted(1 min post division of LIMA). The operative time required for LIMA dissection was also noted and entered. Patient's s demographic data were also collected and entered.	Procedure: Conventional Arm; This technique uses only the electrocautery as conventional model

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Government Medical College Kottayam
• Investigators: Principal Investigator: Dinesh Kumar Sathanantham, MBBS MS MCh, Government Medical College Kottayam

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: November 24, 2023
• First Submitted That Met QC Criteria: November 24, 2023
• First Posted (Actual): December 4, 2023

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: CABG, LIMA harvesting, CAD
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Myocardial Infarction; Infarction; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 95/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

The two parameters: Operative time and Blood flow/min between two techniques will be shared.

Co-morbidities data will also be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No