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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03210818
Collaborator
(none)
28
1
17.8
1.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
28 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Effects of Adjustment of Blood Flow of Venoarterial Extracorporeal Membrane Oxygenation Life Support on Microcirculation
Actual Study Start Date :
Nov 5, 2017
Actual Primary Completion Date :
Dec 3, 2018
Actual Study Completion Date :
Apr 30, 2019

Outcome Measures

Primary Outcome Measures

  1. Perfused small vessel density [Difference of PSVD between before and after adjustment of VA-ECMO blood flow within 24 hours after placement of VA-ECMO]

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

Secondary Outcome Measures

  1. 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 [PSVD] measured by incident dark field video microscope

  2. 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]

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

  3. 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]

    Total small vessel density [TSVD] measured by incident dark field video microscope

  4. 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]

    Proportion of perfused vessel (PPV): TSVD/PSVD X 100

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Taiwan University Hospital Taipei Taiwan 110

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

  • Principal Investigator: Yu-Chang Yeh, MD, PhD, National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT03210818
Other Study ID Numbers:
  • 201703011RINA
First Posted:
Jul 7, 2017
Last Update Posted:
May 9, 2019
Last Verified:
Jul 1, 2018
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 9, 2019