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

Completed

• Conditions: Circulatory Failure

• Registration Number: NCT03210818
• Lead Sponsor: National Taiwan University Hospital

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.

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 Timeline

• Study First Submitted: 2017-07-02
• Study First Submitted QC: 2017-07-05
• Study First Posted: 2017-07-07
• Study Start: 2017-11-05
• Status Verified: 2018-07
• Primary Completion: 2018-12-03
• Study Completion: 2019-04-30
• Last Update Submitted: 2019-05-07
• Last Update Posted: 2019-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan