Suspended

Clinical Study of VA-ECMO Remote Limb Re-perfusion Monitoring Technology

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What is being tested

Closed transdyser

+ Routine monitor

Behavioral
Who is being recruted

Over 18 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Placebo-Controlled
Interventional
Study Start: January 2020
See protocol details

Summary

Principal SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Study ContactFei Zeng
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2020

Actual date on which the first participant was enrolled.

It is proposed to monitor VA-ECMO arterial end side branch circulation in real time through a set of monitoring equipment, guide clinical adjustment, improve lower limb re-perfusion, reduce the occurrence of lower limb ischemia, in order to achieve the goal of early detection, early prevention and early treatment, and provide reference and theoretical basis for clinical practice. Monitoring techniques are divided into two parts: A. monitoring equipment (connecting transdiotic monitoring pressure on va-ECMO side branches cycle); B.to guide clinical adjustment by monitoring pressure (average arterial pressure).

Official TitleClinical Study of VA-ECMO Remote Limb Re-perfusion Monitoring Technology
NCT04929873
Principal SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Study ContactFei Zeng
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

72 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
Age: adult patients ≥ 18 years of age;

signed ECMO informed consent;

femur vein VA-ECMO treatment;

agreed to establish VA-ECMO side branch cycle;

Show More Criteria

2 exclusion criteria prevent from participating
a completely closed double lower limb venously before surgery;

amputee

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Immediately after the establishment of the side branch cycle, the closed transdone is connected for real-time monitoring of pressure, and clinical nursing practice is guided by transdictor pressure.

Group II

Placebo
routine nursing

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

SAHZhejiangU

Hangzhou, ChinaOpen SAHZhejiangU in Google Maps
SuspendedOne Study Center