RECOVERY: Hemodynamic Comparison of Peripheral and Central VA ECMO.
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Peripheral VA ECMO Femoral artery cannulation for veno-arterial extracorporeal membraneous oxygenation (VA ECMO) |
Procedure: Veno-arterial extracorporeal membrane oxygenation
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.
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| Central VA ECMO Axillary artery cannulation for veno-arterial extracorporeal membraneous oxygenation (VA ECMO) |
Procedure: Veno-arterial extracorporeal membrane oxygenation
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.
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Outcome Measures
Primary Outcome Measures
- Oxygen saturation-no. (%) [Through VA ECMO support completion, an average of 1 week]
Blood gas analysis
- Left ventricular end-diastolic volume (ml) [Through VA ECMO support completion, an average of 1 week]
echocardiography
- Left ventricular End-systolic volume (ml) [Through VA ECMO support completion, an average of 1 week]
echocardiography
- Stroke volume (ml) [Through VA ECMO support completion, an average of 1 week]
echocardiography
- Mitral valve area(cm2) [Through VA ECMO support completion, an average of 1 week]
echocardiography
Secondary Outcome Measures
- Rate of successful weaning from VA ECMO [Through study completion, up to 2 years]
Weaning success is defined as survival after complete removal of the extracorporeal circuit without requirement for further mechanical support or heart transplant.
- VA ECMO duration [Through VA ECMO support, an average of 1 week]
Length of VA ECMO support
- Cannulation-related complications [Through study completion, up to 2 years]
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.
- Duration of ICU stay [Through study completion, up to 2 years]
Intensive care unit length of stay
- Duration of hospital stay [Through study completion, up to 2 years]
Length of hospital stay
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Ageā„18 years
-
Participants with cardiogenic shock
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Obtaining informed consent from participants or their affiliated beneficiaries
Exclusion Criteria:
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Irreversible heart failure
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Contraindications to anticoagulation therapy
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Uncontrolled bleeding
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Irreversible neurological pathology
-
Participants limited to extracorporeal cardiopulmonary resuscitation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | First Affiliated Hospital of Xian Jiaotong University | Xi'an | Shaanxi | China | 710061 |
Sponsors and Collaborators
- First Affiliated Hospital Xi'an Jiaotong University
- Peking University Third Hospital
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Beijing Anzhen Hospital
- Guangdong Provincial People's Hospital
- Shaanxi Provincial Center for Disease Control and Prevention
Investigators
- Study Director: Yang Yan, First Affiliated Hospital of Xian Jiaotong University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- XJTU1AF2021CRF-005