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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04929873

Enrollment

Registered

2021-06-18

Start date

2020-01-01

Completion date

2022-12-31

Last updated

2021-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perfusion; Complications

Brief summary

Establish and verify the feasibility and effectiveness of VA-ECMO remote limb re-perfusion monitoring technology.

Detailed description

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).

Interventions

BEHAVIORALClosed transdyser

When the average arterial pressure ≥ 50mmHg, it is indicated that the basic blood supply of the lower extremities is satisfied without special treatment, and when the average arterial pressure \< 50mmHg, it indicates insufficient perfusion, by adjusting the pipe position, changing the ECMO flow rate, and properly clamping the artery end to divert part of the blood flow to the side branch circulation, so that the average arterial pressure is maintained above 50mmHg.

BEHAVIORALRoutine monitor

Obtain oxygen saturation, skin color, temperature, etc

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Intervention model description

transdynation for real-time pressure monitoring

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age: adult patients ≥ 18 years of age; * signed ECMO informed consent; * femur vein VA-ECMO treatment; * agreed to establish VA-ECMO side branch cycle; * informed consent to this study.

Exclusion criteria

* a completely closed double lower limb venously before surgery; * amputee

Design outcomes

Primary

Measure	Time frame	Description
Incidence of ischemia Incidence of ischemia	1 year	of ischemia in the lower extremities on the side of the tube

Countries

China

Contacts

Primary ContactFei Zeng

zengfei@zju.edu.cn13757119536

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026