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

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

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

Conditions
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Perfusion; Complications

Intervention / Treatment
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* Behavioral: Closed transdyser
* Behavioral: Routine monitor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: transdynation for real-time pressure monitoring
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: routine treatment<br>routine nursing | Behavioral: Routine monitor<br>* Obtain oxygen saturation, skin color, temperature, etc<br>|
| Experimental: Experimental group<br>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. | Behavioral: Closed transdyser<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of ischemia Incidence of ischemia | of ischemia in the lower extremities on the side of the tube | 1 year |