None listed
Conditions
Brief 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 patients to cardiopulmonary bypass during cardiac surgery. 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. The use of a second downstream cannula or sewing a side graft are methods used to prevent complications from poor blood supply to the lower leg by providing a dedicated blood supply. These techniques are cumbersome, time consuming and require additional equipment. As a result current standard practice involves the use of an upstream femoral cannula only, relying on the very small amount of blood that will flow downstream around the cannula to keep the leg viable. It is hoped that the use of the novel bi-directional femoral perfusion cannula in cardiac surgery will lead to an improvement in current practice by providing a more reliable continuous blood flow down the leg during cardiopulmonary bypass. The aim of this study is to evaluate the safety and performance of the MTMM bi-directional cannula in the cardiac surgery setting and to determine whether this cannula provides adequate downstream blood flow to the limb to avoid complications from poor blood supply.
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 peripheral femoral cannulation for Cardiac Surgery.It is inserted on a single occasion by the cardiothoracic surgeon under direct vision into the femoral artery 5-10 minutes prior to institution of cardiopulmonary bypass (CPB). It remains in situ until approximately 15-30 minutes after the patient is taken off CPB. The p
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 peripheral femoral cannulation for Cardiac Surgery.It is inserted on a single occasion by the cardiothoracic surgeon under direct vision into the femoral artery 5-10 minutes prior to institution of cardiopulmonary bypass (CPB). It remains in situ until approximately 15-30 minutes after the patient is taken off CPB. The patient may be on CPB for up to 240 minutes (but the most common duration is between 90-120 minutes).
Sponsors
Alfred Hospital
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients may be male or female 2. Patients must be 18 years or over and not more than 80 years of age. 3. Patients must be assessed as requiring cardiac surgery with cardiopulmonary bypass support by a cardio-thoracic surgeon. 4. Patients must weigh greater than 45kg and less than 130kg. 5. Site personnel must obtain informed consent from the patient prior to any study procedures (including screening procedures).
Exclusion criteria
1. Patients who have undergone previous vascular surgery of the femoral artery. 2. Patients requiring emergency cardiac surgery including Type A aortic dissections. 3. Patients where the internal diameter of the common femoral artery is not greater than 0.6cm. 4. Concurrent enrollment in another investigational drug or device study, or use of any experimental or investigational drug or device within 30 days of cardiopulmonary bypass support. 5. Any other medical condition which in the view if the Investigator is likely to interfere with the study or put the patient at risk. 6. Patients who the investigator feels will not achieve adequate flow rates and line pressures due to the patient's weight and body surface area.
Outcome results
None listed