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)

Government Medical College Kottayam

Status: Completed

Conditions: Coronary Artery Disease With Myocardial Infarction; Coronary Artery Disease

Treatments: Procedure: Modified Carbo-dissection Technique; Procedure: Conventional Arm

Study type: Interventional

Funder types: Other

Identifiers

NCT06155045

95/2020

Details and patient eligibility

About

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

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Modified Carbo-dissection technique

Experimental group

Description:

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.

Treatment:

Procedure: Modified Carbo-dissection Technique

Conventional Arm

Active Comparator group

Description:

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.

Treatment:

Procedure: Conventional Arm