A Prospective Phase 1 Study of a Novel Bi-Directional Arterial Cannula in Patients requiring Peripheral Veno-Arterial Extra Corporeal Membrane Oxygenation (VA-ECMO) Support.
A prospective, Phase 1, open treatment, non comparative, single centre, device study to evaluate the safety and performance of the MTMM bi-directional cannula in patients undergoing VA-ECMO support.
The Alfred Hospital
15 participants
Jul 1, 2016
Interventional
Conditions
Summary
The aim of this study is to test a novel cannula that permits blood flow up and down the leg (called bi-directional) when placed in the femoral artery for the purposes of connecting the patient to Veno-Arterial Extracorporeal Membrane Oxygenation (V-A ECMO) support. As the cannula needs to be large to allow for a large volume of blood that must pass through the ECMO machine, the diameter of the cannula is almost the same as the diameter of the femoral artery so there is little room around the cannula for the blood to flow down the leg. Complications can arise due to poor blood flow down the leg which may result in irreversible damage to structures in the leg. To overcome this problem, a second cannula or downstream cannula is inserted to provide blood flow down the leg and less frequently a sidegraft to the femoral artery is performed. These techniques are time consuming and cumbersome and can delay the return of blood flow to the leg as the patient is placed on ECMO. The novel bi-directional flow cannula is designed to provide blood flow up and down the leg so that a second downstream cannula is not needed. Blood flow in the leg will be measured while the cannula is in place, using non-invasive ultrasound and non-invasive near infra-red spectroscopy (NIRS) which is a simple, painless, non-invasive way of measuring oxygen in the blood in the leg. Prior testing of the cannula in animal models proved safe and effective.
Eligibility
Inclusion Criteria4
- Must be between18 years and 80 years inclusive.
- Assessed as requiring V-A ECMO support by ICU consultant
- Must weigh between 45kg and 130kg inclusive.
- Site personel must obtain written informed consent from the patient or their legally authorised representative prior to any study procedures
Exclusion Criteria12
- Patients with a history of peripheral vascular disease
- previous peripheral arterial bypass
- diabetic vasculopathy
- Patients with a history of diabetic retinopathy
- Patients with a history of diabetic nephropathy
- Patients where the common femoral artery is not identifiable with vascular ultrasound.
- Patients where the common femoral artery is identifiable with vascular ultrasound but the internal diameter of the femoral artery is not greater than 0.6cm.
- Patients requiring ECMO support to be instituted in the emergency setting during Cardio Pulmonary Resuscitation (CPR).
- Non Alfred Hospital VA ECMO initiation (retrieval)
- Concurrent enrolment in another investigational drug or device study, or use of any experimental or investigational drug or device within 30 days of ECMO support.
- Any other medical condition which in the view of the investigator is likely to interfere with the study or put the participant at risk.
- Patients who the investigator feels may not achieve adequate flow rates and line pressures due to their weight or body height.
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Interventions
The MTMM bi-directional cannula is a novel femoral arterial cannula that has been developed to improve standard retrograde perfusion without compromising distal limb flow during femoral cannulation for Veno-Arterial Extra Corporeal Membrane Oxygenation (V-A ECMO) Support. It is inserted on a single occasion by the ICU ECMO consultant, into the femoral artery prior to institution of ECMO therapy. It remains in situ until ECMO is no longer required to support the patient.
Locations(1)
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ACTRN12615001086550