Negative Venous Line Pressure in a Miniaturised Cardiopulmonary Bypass Circuit (CPB)

University Hospital Plymouth NHS Trust

Status: Completed

Conditions: Heart Surgery

Treatments: Device: Conventional 3-stage venous cannula; Device: Conventional 2-stage venous cannula; Device: Fenestrated 3-stage venous cannula

Study type: Interventional

Funder types: Other

Identifiers

NCT03717649

15/P/003

Details and patient eligibility

About

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.

Full 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)

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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48 participants in 3 patient groups

Conventional 2-stage venous cannulation

Active Comparator group

Description:

The two-stage venous cannula 36Fr and 51Fr (size) for each of the two stages (91251C, Medtronic)

Treatment:

Device: Conventional 2-stage venous cannula

Conventional 3-stage venous cannula

Active Comparator group

Description:

The standard three-stage cannula (91437C, Medtronic) is 29Fr, 46Fr and 37Fr for each of the three stages.

Treatment:

Device: Conventional 3-stage venous cannula

Fenestrated 3-stage venous cannula

Experimental group

Description:

The fenestrated three-stage cannula (MC2X, Medtronic) is 29Fr, 29Fr and 29Fr for each of the three stages.

Treatment:

Device: Fenestrated 3-stage venous cannula