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NCT Number: NCT03210818

Effects 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.

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Key information

Conditions

Circulatory Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Shock

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, 110, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extra-corporeal membrane oxygenation life support

Device

Adjustment of blood flow of extra-corporeal membrane oxygenation life support

Primary outcomes

  1. Perfused small vessel density

    Time frame: 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 outcomes

  1. Perfused small vessel density

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jul 7, 2017
Registry last updated
May 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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