Hemodynamic Comparison of Peripheral and Central VA ECMO.

Study Overview
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Brief Summary
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The goal of this clinical trial is to monitor hemodynamic differences between central veno-arterial extracorporeal membrane oxygenation (VA ECMO) and peripheral VA ECMO. The main question it aims to answer is: Efficacy of the different cannulation strategies for the establishment of for VA-ECMO circulation on hemodynamics and organ perfusion. Participants require VA ECMO support, will be divided into two groups in an intention-to-treat analysis: central artery cannulation and peripheral artery cannulation. Researchers will analyze different cannulation strategies for VA-ECMO and identify potential advantages and disadvantages for two groups of VA-ECMO.

Official Title
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Comparison of Peripheral and Central Intubation on Hemodynamics in Veno-arterial-extracorporeal Membrane Oxygenation (RECOVERY): a National, Multi-center, Prospective, Cohort Study

Conditions
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Shock, Cardiogenic, Cardiac Arrest, Extracorporeal Circulation; Complications, Hemodynamics Instability

Intervention / Treatment
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* Procedure: Veno-arterial extracorporeal membrane oxygenation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age≥18 years Participants with cardiogenic shock Obtaining informed consent from participants or their affiliated beneficiaries Exclusion Criteria: Irreversible heart failure Contraindications to anticoagulation therapy Uncontrolled bleeding Irreversible neurological pathology Participants limited to extracorporeal cardiopulmonary resuscitation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Peripheral VA ECMO<br>Femoral artery cannulation for veno-arterial extracorporeal membraneous oxygenation (VA ECMO) | Procedure: Veno-arterial extracorporeal membrane oxygenation<br>* Veno-arterial extracorporeal membrane oxygenation (VA ECMO) is mainly used for circulatory support in patients with severe cardiopulmonary failure. VA ECMO drains the blood from the venous system followed pumping the blood back into the arterial vascular compartment after oxygenation. It can be divided into two cannulation strategies for VA ECMO support, namely peripheral VA ECMO and central VA ECMO based on the arterial cannulation site. Peripheral VA ECMO is established via the femoral artery (FA), whereas axillary artery (AX) is an arterial cannulation site in central VA-ECMO.<br>|
| Central VA ECMO<br>Axillary artery cannulation for veno-arterial extracorporeal membraneous oxygenation (VA ECMO) | Procedure: Veno-arterial extracorporeal membrane oxygenation<br>* Veno-arterial extracorporeal membrane oxygenation (VA ECMO) is mainly used for circulatory support in patients with severe cardiopulmonary failure. VA ECMO drains the blood from the venous system followed pumping the blood back into the arterial vascular compartment after oxygenation. It can be divided into two cannulation strategies for VA ECMO support, namely peripheral VA ECMO and central VA ECMO based on the arterial cannulation site. Peripheral VA ECMO is established via the femoral artery (FA), whereas axillary artery (AX) is an arterial cannulation site in central VA-ECMO.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen saturation-no. (%) | Blood gas analysis | Through VA ECMO support completion, an average of 1 week | 
| Left ventricular end-diastolic volume (ml) | echocardiography | Through VA ECMO support completion, an average of 1 week | 
| Left ventricular End-systolic volume (ml) | echocardiography | Through VA ECMO support completion, an average of 1 week | 
| Stroke volume (ml) | echocardiography | Through VA ECMO support completion, an average of 1 week | 
| Mitral valve area(cm2) | echocardiography | Through VA ECMO support completion, an average of 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of successful weaning from VA ECMO | Weaning success is defined as survival after complete removal of the extracorporeal circuit without requirement for further mechanical support or heart transplant. | Through study completion, up to 2 years | 
| VA ECMO duration | Length of VA ECMO support | Through VA ECMO support, an average of 1 week | 
| Cannulation-related complications | Cannulation-related complications include bleeding, limb ischemia, revision of cannulation site, wound complications. Limb ischemia is defined as ischemia requiring any surgical procedure, including revision of the arterial/distal perfusion cannula, fasciotomy for compartment syndrome, gangrene, or amputation. Wound complication is defined as infection or requirement of an additional surgical intervention, such as arterial repair, washout with or without vacuum-assisted closure, and muscle flap closure. | Through study completion, up to 2 years | 
| Duration of ICU stay | Intensive care unit length of stay | Through study completion, up to 2 years | 
| Duration of hospital stay | Length of hospital stay | Through study completion, up to 2 years |