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

Not Applicable

• Conditions: Perfusion; Complications
• Interventions: Behavioral: Routine monitor; Behavioral: Closed transdyser

• Registration Number: NCT04929873
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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).

Study Timeline

• Study Start: 2020-01-01
• Status Verified: 2021-05
• Study First Submitted: 2021-06-01
• Study First Submitted QC: 2021-06-10
• Last Update Submitted: 2021-06-10
• Study First Posted: 2021-06-18
• Last Update Posted: 2021-06-18
• Primary Completion: 2021-10-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
routine treatment	Routine monitor	routine nursing
Experimental group	Closed transdyser	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.

Primary Outcome Measures

Name	Time	Method
Incidence of ischemia Incidence of ischemia	1 year	of ischemia in the lower extremities on the side of the tube

Trial Locations

Locations (1)

SAHZhejiangU; 🇨🇳 Hangzhou, Zhejiang, China