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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-12

Study Completion Date

2016-10-31

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Heart Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

A single centre, prospective, randomised, double-blind trial

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Conventional 2-stage venous cannulation

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

Group Type ACTIVE_COMPARATOR

Conventional 2-stage venous cannula

Intervention Type DEVICE

venous cannula

Conventional 3-stage venous cannula

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

Group Type ACTIVE_COMPARATOR

Conventional 3-stage venous cannula

Intervention Type DEVICE

venous cannula

Fenestrated 3-stage venous cannula

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

Group Type EXPERIMENTAL

Fenestrated 3-stage venous cannula

Intervention Type DEVICE

venous cannula

Interventions

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Conventional 2-stage venous cannula

venous cannula

Intervention Type DEVICE

Conventional 3-stage venous cannula

venous cannula

Intervention Type DEVICE

Fenestrated 3-stage venous cannula

venous cannula

Intervention Type DEVICE

Eligibility Criteria

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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.