Skeletonised Versus Pedicled Internal Thoracic Artery - A Randomised Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 165
- 试验地点
- 2
- 主要终点
- Differences in flow in LIMA and pulssatility index between the three groups.
研究概览
简要总结
It is to date unknown whether Thunderbeat has a place in harvesting the left internal mammary artery (LIMA) and whether skeletonisation is superior to pedicle harvested LIMA. Though, some studies have shown improved flow-rates in the skeletonised graft while others shows compromised blood flow to the thoracic wall after pedicle harvested LIMA.
The purpose of this study is to improve the quality of life for patients undergoing coronary artery bypass graft (CABG) operations.
The aim of this study is to compare three groups of LIMA harvesting techniques: Pedicled, surgical skeletonised and skeletonised with Thunderbeat to determine the best way to harvest LIMA during CABG operations.
The study design is an experimental randomized controlled trial in a single centre.
Study population: Adult patients enlisted for elective stand-alone CABG surgery at the Department of Cardiothoracic surgery, Odense University Hospital.
Study Unit: Test-days within subject and subject
The study will address two main hypotheses in CABG patients:
- That both the surgical skeletonised and Thunderbeat skeletonised harvesting techniques of LIMA are superior to pedicled harvesting in regards to flowrates and pulsatility index (PI).
- Skeletonized harvesting of LIMA graft compared to pedicled harvesting improves patient quality of life three days, 30 days, and six months postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
After randomisation, the attending consultant informed the patient of the harvesting method. Data collector and outcome adjudicator were blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stand-alone CABG (surgical removal of the left atrial appendage (LAAX) is accepted, since it doesn't affect the graft area)
- •On-pump with cardioplegia (otherwise one cannot be sure of the pressure and perfusion during surgery of the graft)
- •Patients aged >18
- •Elective surgery (there is a known higher risk of postoperative complications with urgent surgery)
排除标准
- •CABG combined with other heart surgery, except from LAAX
- •Previous heart surgery
- •LVEF < 40% (there is a known higher risk of postoperative complications with low LVEF)
- •Known cancers (there is a known higher risk of postoperative complication)
- •Thoracic radiation therapy (there is a known higher risk of postoperative complication)
- •Severe chronic obstructive pulmonary disease (COPD) (there is a known higher risk of postoperative complication)
- •Patients not able to understand written consent
- •Urgent and emergent surgery (there is a known higher risk of postoperative complication)
结局指标
主要结局
Differences in flow in LIMA and pulssatility index between the three groups.
时间窗: Perioperative - After weaning off the extracorporeal circulation just before closing the thorax
mL/ min With transit time flowmetry (Sono TT flowlab), the graft flow and peripheral index (PI) are measured after weaning off the extracorporeal circulation with a systolic pressure aimed at 100 mmHg. The measurements are done with probe size 3 or 4.
次要结局
- Length of stay on ICU(Day of surgery to the day of discharge from ICU. Up to 52 weeks)
- Postoperative bleeding(Postoperative bleeding is measured from the end of the operation to removal of the mediastinal drains in the intensive care unit)
- Rate of all-cause mortality - Early(Early (≤30 days))
- Rate of readmission to hospital due to Major adverse cardiac and cerebrovascular events (MACCE) - Intermediate(Intermediate (≤180 days))
- Differences in pre and post operative regional oxygen saturation on the thorax.(Measured 7 days prior to surgery and again 3 days after surgery)
- Rate of mortality due to cardiac event - Early(Early (≤30 days))
- Rate of mortality due to cardiac event - Iong(Long (≤2 years))
- Re-operation due to ischemia(Up to 48 hours calculated from the end of primaery surgery)
- Re-operation due to bleeding(Up to 48 hours calculated from the end of primaery surgery)
- Myocardial injury - creatine kinase-MB (CK-MB)(Routine bloodsample measured four hours after aortic cross clamp removal.)
- Myocardial injury - cardiac troponin (cTn)(Routine bloodsample measured four hours after aortic cross clamp removal.)
- Length of stay in hospital(Day of surgery to the day of discharge from hospital. Up to 52 weeks)
- Pleurocentesis(Up to 10 days calculated from the end of primaery surgery)
- Rate of mortality due to cardiac event - Intermediate(Intermediate (≤180 days))
- Rate of all-cause mortality - long(Long (≤ 2 years))
- EQ-5D-5L questionnaire: differences in self reported assessment of patient quality of life between the 3 groups(Questionnaires uptained the week before the date of surgery and again 3, 30, and 180 days after surgery.)
- Telephone interview - Questions regarding pain, numbness and wound healing around the thoracic incision.(180 ± 7 days calculated from the date of surgery.)
- Rate of readmission to hospital due to Major adverse cardiac and cerebrovascular events (MACCE) - early(Early (≤30 days))
- Rate of readmission to hospital due to Major adverse cardiac and cerebrovascular events (MACCE) - Long(Long (≤2 years))
- Rate of all-cause mortality - Intermediate(Intermediate (≤180 days))
研究者
Lars Peter Riber
MD, Associate Professor, Ph.D., DMSc
Odense University Hospital