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

NCT03717649 | Completed

• 1 other identifier: 15/P/003
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Surgery

Outcome Measures

Primary Outcomes (1)

• Average blood flow

  Average blood flow measured in litres per minute per body surface area meter (squared).

  duration of surgery

Secondary Outcomes (4)

• Negative pressure readings

  duration of surgery

• Number of microbubbles

  duration of surgery

• Size of microbubbles

  duration of surgery

• Haemolysis

  duration of surgery

Study Arms (3)

Conventional 2-stage venous cannulation

ACTIVE COMPARATOR

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

Device: Conventional 2-stage venous cannula

Conventional 3-stage venous cannula

ACTIVE COMPARATOR

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

Device: Conventional 3-stage venous cannula

Fenestrated 3-stage venous cannula

EXPERIMENTAL

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

Device: Fenestrated 3-stage venous cannula

Interventions

Conventional 2-stage venous cannula DEVICE

venous cannula

Conventional 2-stage venous cannulation

Conventional 3-stage venous cannula DEVICE

venous cannula

Conventional 3-stage venous cannula

Fenestrated 3-stage venous cannula DEVICE

venous cannula

Fenestrated 3-stage venous cannula

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Re-operation and emergency surgery
• Patients refusing or unable to provide informed consent

Sponsors & Collaborators

• University Hospital Plymouth NHS Trust: lead

Study Officials

• Mark Bennett, MD

  University Hospitals Plymouth NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single centre, prospective, randomised, double-blind trial

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: October 24, 2018
• Study Start: January 12, 2016
• Primary Completion: October 31, 2016
• Study Completion: October 31, 2016
• Last Updated: October 24, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share