Negative Venous Line Pressure in a Miniaturised Cardiopulmonary Bypass Circuit - the Influence of a Fenestrated Venous Cannula and Its Effect on Pump Flow
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 主要终点
- Average blood flow
研究概览
简要总结
Study to measure the ability of a 'fenestrated' venous line cannula to reduce the negative line pressure seen with kinetic-assist active venous drainage (KAVD) in a standard miniaturised cardiopulmonary bypass circuit and thereby increase the flow characteristics of the bypass pump.
详细描述
To investigate whether a new venous drainage pipe (cannula) which has three sets of drainage holes (three-stage) compared with the standard two-stage cannula, or a three-stage which also has additional windows (fenestrations), can improve the drainage of blood into the circuit, reducing the negative pressure produced and increase the blood flow delivered to the patient. Patients who consent to participate will be randomly assigned to one of three types of venous cannula:
- Standard venous cannulation with a two-stage venous cannula
- The three-stage cannula (91437C, Medtronic)
- The fenestrated three-stage cannula (MC2X, Medtronic)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •All patients over the age of 18 years of age scheduled to undergo isolated Coronary Artery Bypass Grafting (CABG) or isolated Aortic Valve Replacement (AVR), who are able and willing to consent.
- •Consultant surgeon willing to operate using either Mini-CPB for CABG or AVR surgery.
排除标准
- •Re-operation and emergency surgery
- •Patients refusing or unable to provide informed consent
研究组 & 干预措施
Conventional 2-stage venous cannulation
The two-stage venous cannula 36Fr and 51Fr (size) for each of the two stages (91251C, Medtronic)
干预措施: Conventional 2-stage venous cannula (Device)
Conventional 3-stage venous cannula
The standard three-stage cannula (91437C, Medtronic) is 29Fr, 46Fr and 37Fr for each of the three stages.
干预措施: Conventional 3-stage venous cannula (Device)
Fenestrated 3-stage venous cannula
The fenestrated three-stage cannula (MC2X, Medtronic) is 29Fr, 29Fr and 29Fr for each of the three stages.
干预措施: Fenestrated 3-stage venous cannula (Device)
结局指标
主要结局
Average blood flow
时间窗: duration of surgery
Average blood flow measured in litres per minute per body surface area meter (squared).
次要结局
- Negative pressure readings(duration of surgery)
- Number of microbubbles(duration of surgery)
- Size of microbubbles(duration of surgery)
- Haemolysis(duration of surgery)