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

NCT04929873 | Unknown

• 1 other identifier: 2020-567
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Perfusion; Complications

Outcome Measures

Primary Outcomes (1)

• Incidence of ischemia Incidence of ischemia

  of ischemia in the lower extremities on the side of the tube

  1 year

Study Arms (2)

routine treatment

PLACEBO COMPARATOR

routine nursing

Behavioral: Routine monitor

Experimental group

EXPERIMENTAL

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

Interventions

Closed transdyser 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.

Experimental group

Routine monitor BEHAVIORAL

Obtain oxygen saturation, skin color, temperature, etc

routine treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• a completely closed double lower limb venously before surgery;
• amputee

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

SAHZhejiangU

Hangzhou, Zhejiang, 310000, China

RECRUITING

Study Officials

• Fei Zeng

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

Central Study Contacts

Fei Zeng

CONTACT

13757119536; zengfei@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: transdynation for real-time pressure monitoring

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 18, 2021
• Study Start: January 1, 2020
• Primary Completion: October 30, 2021
• Study Completion: December 31, 2022
• Last Updated: June 18, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)