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

Negative Venous Line Pressure in a Miniaturised Cardiopulmonary Bypass Circuit - the Influence of a Fenestrated Venous Cannula and Its Effect on Pump Flow

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.

Study Overview

• Status: Completed
• Conditions: Heart Surgery
• Intervention / Treatment: Device: Conventional 2-stage venous cannula; Device: Conventional 3-stage venous cannula; Device: Fenestrated 3-stage venous cannula

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)

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional 2-stage venous cannulation; The two-stage venous cannula 36Fr and 51Fr (size) for each of the two stages (91251C, Medtronic)	Device: Conventional 2-stage venous cannula; venous cannula
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.	Device: Conventional 3-stage venous cannula; venous cannula
Experimental: Fenestrated 3-stage venous cannula; The fenestrated three-stage cannula (MC2X, Medtronic) is 29Fr, 29Fr and 29Fr for each of the three stages.	Device: Fenestrated 3-stage venous cannula; venous cannula

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital Plymouth NHS Trust
• Investigators: Principal Investigator: Mark Bennett, MD, University Hospitals Plymouth NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2016
• Primary Completion (Actual): October 31, 2016
• Study Completion (Actual): October 31, 2016

Study Registration Dates

• First Submitted: October 5, 2018
• First Submitted That Met QC Criteria: October 23, 2018
• First Posted (Actual): October 24, 2018

Study Record Updates

• Last Update Posted (Actual): October 24, 2018
• Last Update Submitted That Met QC Criteria: October 23, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 15/P/003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No current plan to share data, but would consider if approached.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No