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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional 2-stage venous cannulation | Active Comparator | The two-stage venous cannula 36Fr and 51Fr (size) for each of the two stages (91251C, Medtronic) |
|
| Conventional 3-stage venous cannula | Active Comparator | The standard three-stage cannula (91437C, Medtronic) is 29Fr, 46Fr and 37Fr for each of the three stages. |
|
| Fenestrated 3-stage venous cannula | Experimental | The fenestrated three-stage cannula (MC2X, Medtronic) is 29Fr, 29Fr and 29Fr for each of the three stages. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional 2-stage venous cannula | Device | venous cannula |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Average blood flow | Average blood flow measured in litres per minute per body surface area meter (squared). | duration of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Negative pressure readings | The duration and depth of negative pressure readings from the venous line during cardiopulmonary bypass (CPB) are made in negative pressure readings in mmHg. | duration of surgery |
| Number of microbubbles |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Bennett, MD | University Hospital Plymouth NHS Trust | Principal Investigator |
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No current plan to share data, but would consider if approached.
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A single centre, prospective, randomised, double-blind trial
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| Conventional 3-stage venous cannula |
| Device |
venous cannula |
|
| Fenestrated 3-stage venous cannula | Device | venous cannula |
|
Measured as total count (n).
| duration of surgery |
| Size of microbubbles | Measured as total volume (ml). | duration of surgery |
| Haemolysis | 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. | duration of surgery |