Microcirculation in Venoarterial Extracorporeal Membrane Oxygenation Life Support

Study Overview
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Brief Summary
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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 organs to recovery or for these patients to receive further management. However, many patients will die in spite of ECMO support. One of the key factor is whether the blood flow provided by the ECMO can meet the requirement of organ perfusion. The adequacy of macrocirculation may be determined by arterial pressure and minute blood flow of ECMO. However, the adequacy of microcirculation remains as a major unresolved clinical problem. This is a prospective observational clinical trial. The sublingual microcirculation will be examined with the incident dark field video microscope within 6 hours after venoarterial ECMO placement, and then at 24 h, 48 h, 72 h, and 96 h. The severity of multiple organ injury and clinical data will be recorded as well. The major parameters of microcirculation include total small vessel density, perfused small vessel density, and microvascular flow index. The sublingual microcirculation will also be examined before weaning off ECMO, within 6 hours after ECMO removal, and then at 24 h, 48 h, and 72 h. Serum level of endothelial cell specific molecule-1 at specific time points will be examined. The data of 14-day mortality, 28-day mortality, duration of ECMO support, and intensive care unit stay will be recorded. This study aims primarily to investigate the relationship between microcirculation and prognosis of these patients. This study will also investigate the relationship among serum level of endothelial cell specific molecule-1, microcirculation, and prognosis of these patients. Wish the results of this study can be applied in further research to help to improve the quality of ECMO care.

Official Title
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Investigation of Microcirculation in Patients With Venoarterial Extracorporeal Membrane Oxygenation Life Support

Conditions
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Heart Failure, Respiratory Failure

Intervention / Treatment
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* Device: Extra-corporeal membrane oxygenation life support


Participation Criteria
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Eligibility Criteria
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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 6 hours after placement of venoarterial ECMO support Non-native speakers

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 28-day Survival<br>survive for at least 28 days after placement of extra-corporeal membrane oxygenation life support | Device: Extra-corporeal membrane oxygenation life support<br>* venoarterial extra-corporeal membrane oxygenation life support<br>|
| 28-day Nonsurvival<br>not survive for 28 days after placement of extra-corporeal membrane oxygenation life support | Device: Extra-corporeal membrane oxygenation life support<br>* venoarterial extra-corporeal membrane oxygenation life support<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perfused small vessel density | Perfused small vessel density measured by incident dark field video microscope | At enrollment (within 12 hour after placement of extra-corporeal membrane oxygenation life support) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total small vessel density | Total small vessel density measured by incident dark field video microscope | At Enrollment | 
| Endocan level |  | At enrollment | 
| Microvascular flow index | Microvascular flow index measured by incident dark field video microscope | At enrollment |