Effects of Blood Flow of Venoarterial Extracorporeal Membrane Oxygenation Life Support on Microcirculation

NCT03210818 | Completed

• 1 other identifier: 201703011RINA
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Extra-corporeal membrane oxygenation (ECMO) life support system can provide both cardiac and respiratory support to patients with heart and respiratory failure. It can save time for these patients to regain organ function or to receive transplantation. Both the investigators' team and Ince et al. from the Netherland found that the microcirculatory dysfunction is more severe in ECMO non-survivors. The next step of research is to find out the key factors that affect microcirculation in ECMO patients. Because the blood flow supplied by the venoarterial ECMO (VA-ECMO) is directly related to macrocirculation, this study aims to investigate the effect of adjustment of VA-ECMO blood flow on microcirculation. The investigators hope that the results of this study can help the medical team to improve the quality of ECMO care.

Conditions

Circulatory Failure

Outcome Measures

Primary Outcomes (1)

• Perfused small vessel density

  Perfused small vessel density \[PSVD\] measured by incident dark field video microscope

  Difference of PSVD between before and after adjustment of VA-ECMO blood flow within 24 hours after placement of VA-ECMO

Secondary Outcomes (4)

• Perfused small vessel density

  Difference of PSVD between before and after adjustment of VA-ECMO blood flow on day 2 after placement of VA-ECMO

• Perfused small vessel density

  Difference of PSVD between before and after adjustment of VA-ECMO blood flow within anticipated 72 hours before removal of VA-ECMO

• Total small vessel density

  Difference of TSVD between before and after adjustment of VA-ECMO blood flow within 24 hours after placement of VA-ECMO

• Proportion of perfused vessel

  Difference of PPV between before and after adjustment of VA-ECMO blood flow within 24 hours after placement of VA-ECMO

Interventions

Extra-corporeal membrane oxygenation life support DEVICE

Adjustment of blood flow of extra-corporeal membrane oxygenation life support

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who require venoarterial extra-corporeal membrane oxygenation (ECMO) life support

You may qualify if:

• Patients who require venoarterial extra-corporeal membrane oxygenation (ECMO) life support

You may not qualify if:

• who can not take an examination of sublingual microcirculation within 24 hours after placement of venoarterial ECMO support
• Non-native speakers

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yu-Chang Yeh, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2017
• First Posted: July 7, 2017
• Study Start: November 5, 2017
• Primary Completion: December 3, 2018
• Study Completion: April 30, 2019
• Last Updated: May 9, 2019

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)