Cerebral Microemboli in Venoarterial ECMO Patients

Study Overview
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Brief Summary
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Extracorporeal membrane oxygenation (ECMO) is progressively used in critically ill patients with cardiac or respiratory failure as a bridging option for potential organ recovery. However, ECMO survivors often suffer from poor neurocognitive outcome due to neurological complications such as microembolic (ME) strokes. In venoarterial (va) ECMO circuits the pulmonary circulation, which usually serves as microembolic filter, may be bypassed and generated ME are prone to reach the brain in substantial amounts and potentially impair cerebral integrity. Although patient exposure to cerebral ME has been thoroughly investigated in cardiopulmonary bypass procedures, there is only limited research on cerebral ME in patients undergoing ECMO therapy. The primary study goal of this study is to determine the load and nature of cerebral ME in critically ill patients under va-ECMO support. We also aim to compare the results to measurements in healthy subjects und intensive care unit (ICU) patients without extracorporeal support to get a better impression on the relevance of ME generation during ECMO support.

Detailed Description
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The addition of ICU patients was made according to reviewer suggestions after an initial submission to a medical journal.

Official Title
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Cerebral Microemboli in Critically Ill Patients Undergoing Venoarterial Extracorporeal Membrane Oxygenation

Conditions
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Complication of Extracorporeal Membrane Oxygenation, Cerebral Microembolism, Cerebral Perfusion

Intervention / Treatment
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* Device: Transcranial Doppler Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (for patients): Intensive care patients with cardiac or respiratory failure under va-ECMO therapy Age > 18 yrs. Signed informed consent Exclusion Criteria: use of any other extracorporeal device including venovenous (vv) ECMO continuous renal replacement therapy medical history of severe mitral or aortic stenosis medical history of severe mitral or aortic regurgitation medical history of carotid stenosis > 70 % septicaemia medical history of vascular dementia or Alzheimer's disease inclusion in an other clinical study gravidity allergy against materials of one of the medical device used in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient on ECMO<br>Neurological monitoring with transcranial Doppler ultrasound | Device: Transcranial Doppler Ultrasound<br>* Transcranial Doppler Ultrasound is used to monitor cerebral microembolism<br>|
| Healthy subjects<br>Neurological monitoring with transcranial Doppler ultrasound | Device: Transcranial Doppler Ultrasound<br>* Transcranial Doppler Ultrasound is used to monitor cerebral microembolism<br>|
| ICU patients<br>Neurological monitoring with transcranial Doppler ultrasound | Device: Transcranial Doppler Ultrasound<br>* Transcranial Doppler Ultrasound is used to monitor cerebral microembolism<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral embolic load | Cerebral embolic load (solid and gaseous) is measured in a 30 minutes-interval during ECMO usage | 30 minutes |