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

Overview

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 Title of Study: “Negative Venous Line Pressure in a Miniaturised Cardiopulmonary Bypass Circuit – the Influence of a Fenestrated Venous Cannula and Its Effect on Pump Flow”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: October 31, 2016

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

  • Device: Conventional 2-stage venous cannula
    • venous cannula
  • Device: Conventional 3-stage venous cannula
    • venous cannula
  • Device: Fenestrated 3-stage venous cannula
    • venous cannula

Arms, Groups and Cohorts

  • Active Comparator: Conventional 2-stage venous cannulation
    • The two-stage venous cannula 36Fr and 51Fr (size) for each of the two stages (91251C, Medtronic)
  • Active Comparator: Conventional 3-stage venous cannula
    • The standard three-stage cannula (91437C, Medtronic) is 29Fr, 46Fr and 37Fr for each of the three stages.
  • Experimental: Fenestrated 3-stage venous cannula
    • The fenestrated three-stage cannula (MC2X, Medtronic) is 29Fr, 29Fr and 29Fr for each of the three stages.

Clinical Trial Outcome Measures

Primary Measures

  • Average blood flow
    • Time Frame: duration of surgery
    • Average blood flow measured in litres per minute per body surface area meter (squared).

Secondary Measures

  • Negative pressure readings
    • Time Frame: 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
    • Time Frame: duration of surgery
    • Measured as total count (n).
  • Size of microbubbles
    • Time Frame: duration of surgery
    • Measured as total volume (ml).
  • Haemolysis
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital Plymouth NHS Trust
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mark Bennett, MD, Principal Investigator, University Hospitals Plymouth NHS Trust

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.