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

Circulatory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03210818
• Other study ID #: 201703011RINA
• Status: Completed
• Start date: November 5, 2017
• Est. completion date: April 30, 2019

Study information

• Verified date: July 2018
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 30, 2019
• Est. primary completion date: December 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Circulatory Failure
• Shock

Intervention

Device:
• Extra-corporeal membrane oxygenation life support
Adjustment of blood flow of extra-corporeal membrane oxygenation life support

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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