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

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

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.

Study Overview

• Status: Completed
• Conditions: Circulatory Failure
• Intervention / Treatment: Device: Extra-corporeal membrane oxygenation life support

Detailed Description

After evaluation, explanation, and acquisition of agreement, the sublingual microcirculation will be examined within 24 h and at 48 h after placement of VA-ECMO. The VA-ECMO blood flow will be recorded, and the baseline microcirculation will be examined. After the ECMO technician adjusting the ECMO flow, sublingual microcirculation will be examined 2 minutes after each adjustment, and the change of ECMO blood flow will be recorded. When the ECMO team plans to weaning off the ECMO within 72 h, the sublingual microcirculation will be examined. The VA-ECMO blood flow will be reduced by ECMO technician, and sublingual microcirculation will be examined 2 minutes after each adjustment of the blood flow. The ECMO parameters, medications, and clinical data will be recorded, and the prognosis will be followed up on the 28th day.

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 110
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 on day 2 after placement of VA-ECMO
Perfused small vessel density	Perfused small vessel density measured by incident dark field video Perfused small vessel density [PSVD] measured by incident dark field video	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	Total small vessel density [TSVD] measured by incident dark field video microscope	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	Proportion of perfused vessel (PPV): TSVD/PSVD X 100	Difference of PPV between before and after adjustment of VA-ECMO blood flow within 24 hours after placement of VA-ECMO

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2017
• Primary Completion (Actual): December 3, 2018
• Study Completion (Actual): April 30, 2019

Study Registration Dates

• First Submitted: July 2, 2017
• First Submitted That Met QC Criteria: July 5, 2017
• First Posted (Actual): July 7, 2017

Study Record Updates

• Last Update Posted (Actual): May 9, 2019
• Last Update Submitted That Met QC Criteria: May 7, 2019
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Shock
• Other Study ID Numbers: 201703011RINA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No