Heart Surgery
Conditions
Brief summary
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.
Detailed description
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: 1. Standard venous cannulation with a two-stage venous cannula 2. The three-stage cannula (91437C, Medtronic) 3. The fenestrated three-stage cannula (MC2X, Medtronic)
Interventions
DEVICEConventional 2-stage venous cannula
venous cannula
DEVICEConventional 3-stage venous cannula
venous cannula
DEVICEFenestrated 3-stage venous cannula
venous cannula
Sponsors
University Hospital Plymouth NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
A single centre, prospective, randomised, double-blind trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Re-operation and emergency surgery * Patients refusing or unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average blood flow | duration of surgery | Average blood flow measured in litres per minute per body surface area meter (squared). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Negative pressure readings | duration of surgery | The duration and depth of negative pressure readings from the venous line during cardiopulmonary bypass (CPB) are made in negative pressure readings in mmHg. |
| Number of microbubbles | duration of surgery | Measured as total count (n). |
| Size of microbubbles | duration of surgery | Measured as total volume (ml). |
| Haemolysis | duration of surgery | Differences in the rate of haemolysis associated with the cannula is measured by the relative increase in plasma alanine aminotransferase (ALT) concentration U/l, as a percentage change from baseline at each of 3 later timepoints. |
Outcome results
None listed