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)

Sponsor

Government Medical College Kottayam (Other)

Overall Status

Completed

CT.gov ID

NCT06155045

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Time taken to harvest the artery
Flow of blood between the two techniques

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Coronary Artery Disease With Myocardial Infarction	Procedure: Modified Carbo-dissection Technique Procedure: Conventional Arm	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The interventional group was compared with the conventional group in terms of two parameters : 1) operative time 2) blood flow/minThe interventional group was compared with the conventional group in terms of two parameters : 1) operative time 2) blood flow/min

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jan 1, 2021

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Dec 31, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Elective CABG
Hemodynamically stable CAD patients

Exclusion Criteria:

Re-operation, previous sternotomy (where LIMA is already dissected)
concomitant valve operation, ventricular aneurysm resection
other additional major cardiac procedures
Patients with chronic obstructive pulmonary disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Government Medical College Kottayam	Kottayam	Kerala	India	686008

Sponsors and Collaborators

Government Medical College Kottayam

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Dinesh Kumar Sathanantham, Dr, Government Medical College Kottayam

ClinicalTrials.gov Identifier:

NCT06155045

Other Study ID Numbers:

95/2020

First Posted:

Dec 4, 2023

Last Update Posted:

Dec 4, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dinesh Kumar Sathanantham, Dr, Government Medical College Kottayam

CABG, LIMA harvesting, CAD

Additional relevant MeSH terms:

Coronary Artery Disease

Myocardial Ischemia

Coronary Disease

Myocardial Infarction

Infarction

Study Results

No Results Posted as of Dec 4, 2023