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

Perfusion; Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04929873
• Other study ID #: 2020-567
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Fei Zeng
• Phone: 13757119536
• Email: zengfei[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 31, 2022
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Perfusion; Complications

Intervention

Behavioral:
• 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.
• Routine monitor
Obtain oxygen saturation, skin color, temperature, etc

Locations

Country	Name	City	State
China	SAHZhejiangU	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

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