Hemodynamic Comparison of Peripheral and Central VA ECMO. (RECOVERY)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Arrest; Shock, Cardiogenic; Extracorporeal Circulation; Complications; Hemodynamics Instability
• Intervention / Treatment: Procedure: Veno-arterial extracorporeal membrane oxygenation

• Study Type: Observational
• Enrollment (Estimated): 136

Contacts and Locations

• Study Contact: Name: Yang Yan; Phone Number: 0086-18991232621; Email: yangyan3@xjtu.edu.cn
• Study Contact Backup: Name: Fengwei Guo; Phone Number: 0086-13991259800; Email: guofengwei@xjtu.edu.cn

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • Recruiting
      • First Affiliated Hospital of Xi'an Jiaotong University
      • Contact: Yang Yan; Phone Number: 0086-18991232621; Email: yangyan3@xjtu.edu.cn
      • Contact: Fengwei Guo; Phone Number: 0086-13991259800; Email: guofengwei@xjtu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Participants require VA ECMO support for cardiogenic shock or cardiac arrest.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Collaborators: Peking University Third Hospital; Guangdong Provincial People's Hospital; Beijing Anzhen Hospital; Chinese Academy of Medical Sciences, Fuwai Hospital; Shaanxi Provincial Center for Disease Control and Prevention
• Investigators: Study Director: Yang Yan, First Affiliated Hospital of Xian Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2023
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: October 30, 2022
• First Submitted That Met QC Criteria: December 28, 2022
• First Posted (Actual): December 30, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Shock; Myocardial Infarction; Infarction; Shock, Cardiogenic
• Other Study ID Numbers: XJTU1AF2021CRF-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No