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临床试验/NCT01166841
NCT01166841已完成不适用

The Effect of Percutaneous Superior Venae Cava Cannulation Clamping on Cerebral Near Infrared Spectroscopy During Minimally Invasive Mitral Valve Surgery

Lawson Health Research Institute2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2010年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
2
主要终点
Mean Near Infrared Saturation of the brain

研究概览

简要总结

The use of minimally invasive cardiac surgery has progressed over the last 5-10 years to allow access to the heart through a small incision in the right chest. This avoids the use of a sternotomy incision through the bone in the front of the chest. The benefits of such an approach are cosmetic (smaller incision not easily visible) and faster recovery. The minimally invasive approach also eliminates the risk of sternal wound infection. Minimally invasive cardiac surgery however poses additional challenges; one of the biggest is access to the large blood vessels which need to be cannulated to allow the heart lung machine to function. In conventional surgery, these vessels are easily accessed as they are entering or leaving the heart. In minimally invasive surgery, the cannula are placed into easily accessible arteries and veins, traditionally the femoral vessels. These vessels are smaller than those by the heart and so require smaller cannula, which provide challenges to the heart lung machine. One way around this is to use more cannulae and so cannulation of a vein in the neck is also performed. This cannula however, has been associated with neck hematoma, tearing of the vein and blood loss. While placement of the cannula in the neck is routine at LHSC now, when this surgery was first performed here 10 years ago, it was done so without the neck cannula and with no injury to patients. The purpose of this study therefore, is to more rigorously study the effect of the neck cannula on heart lung bypass, and more specifically to see if oxygen delivery to the organs, and the brain in particular is sufficient to avoid hypoxia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Care Provider)

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

入选标准

  • 18-80 years of age
  • Elective mitral valve repair or replacement.
  • Scheduled to have minimally invasive approach (right thoracotomy)
  • No contraindication to SVC line placement

排除标准

  • Emergency surgery

结局指标

主要结局

Mean Near Infrared Saturation of the brain

时间窗: Baseline within 5 minutes of intervention then Intraoperatively during intervention.

Measure the NIRs of the brain by placeing NIRs monitoring patches on the forehead during clamped and unclamped intervention of the percutaneous superior vena cava line.

次要结局

  • Mean Blood Pressure(Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).)
  • Mean mixed venous saturation (non invasive measure)(Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).)
  • CPB pump flow(Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).)
  • Vacuum Pressure(Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).)
  • Venous reservoir level(Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).)
  • Arterial blood gas(Initial, after first intervention arm(20 min), at end of study period (40 min))
  • Surgical visualization score(Baseline immediately before intervention period , end of each intervention period)
  • cerebral perfusion pressure(Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).)
  • Central Venous Pressure(Intraoperatively during intervention.(every 5 minutes during 40 minute intervention period).)

研究者

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

Daniel Bainbridge

Associate Professor

Lawson Health Research Institute

研究点 (2)

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