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

Sponsor

University Hospital Plymouth NHS Trust (Other)

Overall Status

Completed

CT.gov ID

NCT03717649

Collaborator

(none)

Enrollment

Arms

9.6

Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Heart Surgery	Device: Conventional 2-stage venous cannula Device: Conventional 3-stage venous cannula Device: Fenestrated 3-stage venous cannula	N/A

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:

Standard venous cannulation with a two-stage venous cannula
The three-stage cannula (91437C, Medtronic)
The fenestrated three-stage cannula (MC2X, Medtronic)

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

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

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 12, 2016

Actual Primary Completion Date :

Oct 31, 2016

Actual Study Completion Date :

Oct 31, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Average blood flow [duration of surgery]
Average blood flow measured in litres per minute per body surface area meter (squared).

Secondary Outcome Measures

Negative pressure readings [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 [duration of surgery]
Measured as total count (n).
Size of microbubbles [duration of surgery]
Measured as total volume (ml).
Haemolysis [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital Plymouth NHS Trust

Investigators

Principal Investigator: Mark Bennett, MD, University Hospitals Plymouth NHS Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital Plymouth NHS Trust

ClinicalTrials.gov Identifier:

NCT03717649

Other Study ID Numbers:

15/P/003

First Posted:

Oct 24, 2018

Last Update Posted:

Oct 24, 2018

Last Verified:

Oct 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 24, 2018