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Active, not recruiting Not applicable

Optimized CT-imaging Protocol in VA-ECMO Patients After CPR

NCT05290805 · tracked via the Priya Life Science Austria tracker
Phase
Not applicable
Started
2022-02-01
Last updated
2024-11-22

Condition(s) studied

Cardiopulmonary ArrestVA-ECMO

Investigational drug(s) / intervention(s)

ECMO flow rate reduction

ECMO flow rate reduction: ECMO flow rate is reduced for the duration of CT image acquisition (max. 1-2 min.), if the hemodynamic and respiratory situation allows it. Feasibility is determined by the accompanying emergency physician right before the CT scan and adapted to the individually tolerable level (max. 50% of initial flow, no less than 1,5 litre/min). After image acquisition, ECMO flow rate is immediately returned to the initial or clinically optimal value at this moment.

Study summary

Veno-arterial (VA) extracorporal membrane oxygenation (ECMO) is an increasingly applied method in patients under cardiopulmonary resuscitation (CPR), who are regularly examined with a contrast-enhanced computed tomography to search for the underlying pathology as well as complications from the implantation of the ECMO system or CPR. The extraordinary hemodynamic situation due to VA-cannulation with antegrade and retrograde perfusion is a challenge to the diagnostically required simultaneous opacification of pulmonary and systemic arterial vessels. Evidence regarding the effect of ECMO flow rate, cannula position, cardiac function and contrast agent injection site is scarce and to the best of the authors' knowledge, no standardized scan protocol for this patient collective exists.

In this study, all adult emergency department patients at our institution with femoro-femoral VA-ECMO and ongoing or recent cardiopulmonary resuscitation, who are referred to a clinically indicated CT scan in this context, will be included, aiming for a total of n=50 patients. The first 25 consecutive patients will be assigned to the intervention cohort. For these patients the ECMO flow rate is reduced by a maximum of 50% of initial flow, but to no less than 1,5 liter/min, for the duration of the CT scan (max. 1-2 minutes), given the hemodynamic and respiratory situation allows it. The following 25 consecutive patients will be assigned to the control cohort for whom ECMO flow rate is not reduced. Clinical data (e.g. ECMO flow rate, ventilation parameters, cardiac function, venous line for contrast injection) at the time of imaging will be documented via a standardized data sheet. The applied CT protocol routinely comprises a non-contrast-enhanced cranial CT (CCT), CT angiography (CTA) of the aorta as well as a portal-venous phase of the chest and abdomen. Complementary scans will be performed as clinically indicated.

The aim of this single-center prospective cohort study is to evaluate the performance of an optimized CT protocol for this patient cohort and whether a reduction of ECMO flow rate improves contrast enhancement of critically relevant vessels in these CT examinations in comparison to a non-reduction cohort.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Running or recent eCPR * Clinically indicated CT and CT angiography of chest and abdomen (and head, if required) * Femoro-femoral VA-ECMO-cannulation Exclusion Criteria: \- Contraindication for CT scan or administration of iodinated contrast agent

Primary outcome measure(s)

  • Computed tomography vessel opacification — Three years
    To assess and compare overall vessel opacification of eCPR patients with and without ECMO flow reduction, measured by mean HU in a representative cross-section of clinically relevant vessels.
  • Number and clinical impact of pathological findings — ten days
    To assess the number and clinical impact of additional / previously unknown pathological findings in eCPR patients detected by early post-eCPR CT, measured by direct feedback of the treating emergency physician on the relevance (Likert scale 1-5) and consequences (time and type) of findings.

Trial sites (1)

FacilityCityRegionStatus
Medical University of Vienna Vienna State of Vienna

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05290805 on ClinicalTrials.gov ↗ ← All trials in Austria