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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-12-31

Brief Summary

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

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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).

Conditions

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Perfusion; Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

transdynation for real-time pressure monitoring

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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routine treatment

routine nursing

Group Type PLACEBO_COMPARATOR

Routine monitor

Intervention Type BEHAVIORAL

Obtain oxygen saturation, skin color, temperature, etc

Experimental group

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 Type EXPERIMENTAL

Closed transdyser

Intervention Type BEHAVIORAL

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.

Interventions

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Closed 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.

Intervention Type BEHAVIORAL

Routine monitor

Obtain oxygen saturation, skin color, temperature, etc

Intervention Type BEHAVIORAL

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.