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

Heart Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03717649
• Other study ID #: 15/P/003
• Status: Completed
• Phase: N/A
• Start date: January 12, 2016
• Est. completion date: October 31, 2016

Study information

• Verified date: October 2018
• Source: University Hospital Plymouth NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 31, 2016
• Est. primary completion date: October 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Surgery

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Plymouth NHS Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average blood flow	Average blood flow measured in litres per minute per body surface area meter (squared).	duration of surgery
Secondary	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
Secondary	Number of microbubbles	Measured as total count (n).	duration of surgery
Secondary	Size of microbubbles	Measured as total volume (ml).	duration of surgery
Secondary	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