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)

Not Applicable

Completed

• Conditions: Coronary Artery Disease With Myocardial Infarction; Coronary Artery Disease
• Interventions: Procedure: Conventional Arm; Procedure: Modified Carbo-dissection Technique

• Registration Number: NCT06155045
• Lead Sponsor: Government Medical College Kottayam

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

1. Time taken to harvest the artery

2. Flow of blood between the two techniques

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 Timeline

• Study Start: 2021-01-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Study First Submitted: 2023-11-24
• Study First Submitted QC: 2023-11-24
• Status Verified: 2023-12
• Study First Posted: 2023-12-04
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Arm	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.
Modified Carbo-dissection technique	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Government Medical College Kottayam; 🇮🇳 Kottayam, Kerala, India