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Clinical Trials/NCT04929873
NCT04929873UnknownNot Applicable

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

Second Affiliated Hospital, School of Medicine, Zhejiang University1 site in 1 country72 target enrollmentStarted: January 1, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
72
Locations
1
Primary Endpoint
Incidence of ischemia Incidence of ischemia

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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;

Arms & Interventions

routine treatment

Placebo Comparator

routine nursing

Intervention: Routine monitor (Behavioral)

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.

Intervention: Closed transdyser (Behavioral)

Outcomes

Primary Outcomes

Incidence of ischemia Incidence of ischemia

Time Frame: 1 year

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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