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)

NCT ID: NCT06155045

Last Updated: 2023-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-12-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Coronary Artery Disease Coronary Artery Disease With Myocardial Infarction

Keywords

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CABG, LIMA harvesting, CAD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Modified Carbo-dissection Technique

Intervention Type PROCEDURE

This technique comes the C02 blower with electrocautery. Thereby, producing vasodilatation due to the gas and dissection aided by the electrocautery.

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.

Group Type ACTIVE_COMPARATOR

Conventional Arm

Intervention Type PROCEDURE

This technique uses only the electrocautery as conventional model

Interventions

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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.

Intervention Type PROCEDURE

Conventional Arm

This technique uses only the electrocautery as conventional model

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Government Medical College Kottayam

OTHER

Sponsor Role lead

Responsible Party

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Dinesh Kumar Sathanantham

Resident in Dept. of Cardiovascular and Thoracic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dinesh Kumar Sathanantham, MBBS MS MCh

Role: PRINCIPAL_INVESTIGATOR

Government Medical College Kottayam

Locations

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Government Medical College Kottayam

Kottayam, Kerala, India

Site Status

Countries

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India

References

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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.

Reference Type BACKGROUND
PMID: 29300076 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15354091 (View on PubMed)

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.

Reference Type RESULT
PMID: 3140750 (View on PubMed)

Nair JTK, Sathanantham DK, Thomas JK. Comparison of conventional and modified carbo-dissection techniques for LIMA harvesting in CABG. Indian J Thorac Cardiovasc Surg. 2025 Feb;41(2):162-166. doi: 10.1007/s12055-024-01780-z. Epub 2024 Jul 15.

Reference Type DERIVED
PMID: 39822879 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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95/2020

Identifier Type: -

Identifier Source: org_study_id