Hemodynamic Comparison of Peripheral and Central VA ECMO.

Cardiac Arrest Clinical Trial

— RECOVERY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05669183
• Other study ID #: XJTU1AF2021CRF-005
• Status: Recruiting
• Start date: August 12, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Yang Yan
• Phone: 0086-18991232621
• Email: yangyan3[@]xjtu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: December 31, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (6)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	Beijing Anzhen Hospital, Chinese Academy of Medical Sciences, Fuwai Hospital, Guangdong Provincial People's Hospital, Peking University Third Hospital, Shaanxi Provincial Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen saturation-no. (%)	Blood gas analysis	Through VA ECMO support completion, an average of 1 week
Primary	Left ventricular end-diastolic volume (ml)	echocardiography	Through VA ECMO support completion, an average of 1 week
Primary	Left ventricular End-systolic volume (ml)	echocardiography	Through VA ECMO support completion, an average of 1 week
Primary	Stroke volume (ml)	echocardiography	Through VA ECMO support completion, an average of 1 week
Primary	Mitral valve area(cm2)	echocardiography	Through VA ECMO support completion, an average of 1 week
Secondary	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
Secondary	VA ECMO duration	Length of VA ECMO support	Through VA ECMO support, an average of 1 week
Secondary	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
Secondary	Duration of ICU stay	Intensive care unit length of stay	Through study completion, up to 2 years
Secondary	Duration of hospital stay	Length of hospital stay	Through study completion, up to 2 years