Cardiogenic Shock Clinical Trial
Official title:
Evaluation of Speckle Tracking Parameters as Predictors of Successful VA ECMO Weaning Procedure. A Prospective Observational Pilot Study.
Purpose of this study is to assess whether measurements obtained through speckle tracking (LV
longitudinal and circumferential strain, RV longitudinal strain) can give additional
information in identifying patients who develop adverse outcomes 30 days post successfully
weaning from VA ECMO (liberation not for palliation). It is a prospective observational
non-blinded pilot study.
In order to achieve this purpose, speckle tracking analysis will be performed on the recorded
images of the transoesophageal echocardiogram performed during the last VA ECMO weaning study
of patients defined ready for VA ECMO liberation. VA ECMO liberation will be based according
to LVOT VTI increase and clinical judgment during patients' VA ECMO weaning study. It will be
assessed whether the population experiencing the outcomes of interest (death within 30 days
from VA ECMO liberation, hospital admission for a new episode of cardiogenic shock or heart
failure within 30 days from VA ECMO liberation, need for new mechanical circulatory support
within 30 days from VA ECMO liberation) and the population not experiencing these outcomes
have different values of strain (LV longitudinal and circumferential and RV longitudinal
strain) during the weaning study.
This project is non-commercial study which aims to assess whether measurements derived
through speckle tracking give additional information to conventional echocardiographic
parameters (LVOT VTI measurements, etc.) in identifying patients at greatest risk of major
clinical events occurring within 30 days after VA ECMO liberation. It is a prospective
observational non-blinded pilot study. In this study will be investigated whether particular
values of strain (longitudinal and circumferential LV longitudinal and circumferential and RV
longitudinal strain) and conventional echocardiographic parameters, obtained during VA ECMO
weaning studies, are more associated to major clinical outcomes within 30 days after VA ECMO
liberation.
The population consists of patients receiving VA ECMO mechanical circulatory support for
cardiogenic shock, who have undergone an echocardiogram as part of the weaning process and a
decision has been made to attempt weaning from VA ECMO. The decision to wean the patient from
VA ECMO will be made by the attending clinician who will be aware of all echocardiographic
measurements with the exception of the speckle tracking results (as is the standard-of-care
at our institution). The study investigator who will perform all speckle tracking analysis
will not be involved in the decision to wean from VA ECMO.
SCHEMATIC OF STUDY DESIGN
1. Screening of VA ECMO patients in whom a weaning study is planned
2. Definitive SCREENING FAILURE = patients who do not fulfil inclusion criteria or have at
least one exclusion criterion (not including the LVOT VTI criterion)
3. VA ECMO weaning study performed
- Patients deemed unsuitable for liberation from VA ECMO at this time are not
enrolled for analysis, and are reassessed following the next weaning study
- Patients deemed suitable for liberation from VA ECMO, but whose LVOT VTI was <10cm
at any stage of the weaning study, or whose LVOT VTI at lowest achieved flow was
lower than baseline are excluded
- Patients deemed suitable for liberation from VA ECMO and not excluded based on LVOT
VTI criterion are enrolled.
4. EVALUATION OF SPECKLE TRACKING FINDINGS (LV LONGITUDINAL AND CIRCUMFERENTIAL AND RV
LONGITUDINAL STRAIN) AND CONVENTIONAL ECHOCARDIOGRAPHIC PARAMETERS WITH CLINICAL
OUTCOMES AT 30 DAYS POST VA ECMO LIBERATION (REMOVAL)
;
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