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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04929873
Collaborator
(none)
72
Enrollment
1
Location
2
Arms
36
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Closed transdyser
  • Behavioral: Routine monitor
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Intervention Model Description:
transdynation for real-time pressure monitoringtransdynation for real-time pressure monitoring
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Clinical Study of VA-ECMO Remote Limb Re-perfusion Monitoring Technology
Actual Study Start Date :
Jan 1, 2020
Anticipated Primary Completion Date :
Oct 30, 2021
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: routine treatment

routine nursing

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

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.

Outcome Measures

Primary Outcome Measures

  1. Incidence of ischemia Incidence of ischemia [1 year]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 SAHZhejiangU Hangzhou Zhejiang China 310000

Sponsors and Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Study Chair: Fei Zeng, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT04929873
Other Study ID Numbers:
  • 2020-567
First Posted:
Jun 18, 2021
Last Update Posted:
Jun 18, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 18, 2021