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

Zhejiang University

Status: Unknown

Conditions: Perfusion; Complications

Treatments: Behavioral: Routine monitor; Behavioral: Closed transdyser

Study type: Interventional

Funder types: Other

Identifiers

NCT04929873

2020-567

Details and patient eligibility

About

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

Full 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).

Enrollment: 72 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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72 participants in 2 patient groups, including a placebo group

routine treatment

Placebo Comparator group

Description:

routine nursing

Treatment:

Behavioral: Routine monitor

Experimental group

Experimental group

Description:

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.

Treatment:

Behavioral: Closed transdyser