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临床试验/NCT06155045
NCT06155045已完成不适用

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

Government Medical College Kottayam1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2021年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
1
主要终点
Operative time

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Elective CABG
  • •Hemodynamically stable CAD patients

排除标准

  • •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

研究组 & 干预措施

Modified Carbo-dissection technique

Experimental

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.

干预措施: Modified Carbo-dissection Technique (Procedure)

Conventional Arm

Active Comparator

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.

干预措施: Conventional Arm (Procedure)

结局指标

主要结局

Operative time

时间窗: 10-20 min

Time taken to perform the harvesting of the LIMA

Blood flow/min

时间窗: 1 min

Post dividing of the LIMA: blood from the LIMA is measured for 1 min

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dinesh Kumar Sathanantham

Resident in Dept. of Cardiovascular and Thoracic Surgery

Government Medical College Kottayam

研究点 (1)

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