NCT05290805

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 22, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

2.4 years

First QC Date

February 21, 2022

Last Update Submit

November 19, 2024

Conditions

Cardiopulmonary ArrestVA-ECMO

Keywords

CPRECMOVessel opacificationComputed tomography

Outcome Measures

Primary Outcomes (2)

  • Computed tomography vessel opacification

    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.

    Three years

  • Number and clinical impact of pathological findings

    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.

    ten days

Secondary Outcomes (4)

  • Subjective CT image quality

    Three years

  • CT vessel opacification homogeneity

    Three years

  • Follow-up CT exams

    Three years

  • Correlations between mean vessel opacification, subjective image quality and appearance of artifacts with intrinsic and extrinsic factors

    Three years

Study Arms (2)

ECMO flow rate reduction

EXPERIMENTAL

In the intervention cohort 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.

Diagnostic Test: ECMO flow rate reduction

no ECMO flow rate reduction

NO INTERVENTION

In this cohort ECMO flow rate is not reduced for CT image acquisition.

Interventions

ECMO flow rate reductionDIAGNOSTIC_TEST

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.

ECMO flow rate reduction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Running or recent eCPR
  • Clinically indicated CT and CT angiography of chest and abdomen (and head, if required)
  • Femoro-femoral VA-ECMO-cannulation

You may not qualify if:

  • \- Contraindication for CT scan or administration of iodinated contrast agent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

Related Publications (9)

  • Lambert L, Grus T, Balik M, Fichtl J, Kavan J, Belohlavek J. Hemodynamic changes in patients with extracorporeal membrane oxygenation (ECMO) demonstrated by contrast-enhanced CT examinations - implications for image acquisition technique. Perfusion. 2017 Apr;32(3):220-225. doi: 10.1177/0267659116677308. Epub 2016 Oct 31.

    PMID: 27799498BACKGROUND

  • Auzinger G, Best T, Vercueil A, Willars C, Wendon JA, Desai SR. Computed tomographic imaging in peripheral VA-ECMO: where has all the contrast gone? J Cardiothorac Vasc Anesth. 2014 Oct;28(5):1307-9. doi: 10.1053/j.jvca.2013.06.027. Epub 2013 Oct 30. No abstract available.

    PMID: 24183316BACKGROUND

  • Kohler K, Valchanov K, Nias G, Vuylsteke A. ECMO cannula review. Perfusion. 2013 Mar;28(2):114-24. doi: 10.1177/0267659112468014. Epub 2012 Dec 20.

    PMID: 23257678BACKGROUND

  • Lee S, Chaturvedi A. Imaging adults on extracorporeal membrane oxygenation (ECMO). Insights Imaging. 2014 Dec;5(6):731-42. doi: 10.1007/s13244-014-0357-x. Epub 2014 Oct 9.

    PMID: 25296619BACKGROUND

  • Acharya J, Rajamohan AG, Skalski MR, Law M, Kim P, Gibbs W. CT Angiography of the Head in Extracorporeal Membrane Oxygenation. AJNR Am J Neuroradiol. 2017 Apr;38(4):773-776. doi: 10.3174/ajnr.A5060. Epub 2017 Jan 5.

    PMID: 28057636BACKGROUND

  • Gullberg Lidegran M, Gordon Murkes L, Andersson Lindholm J, Frenckner B. Optimizing Contrast-Enhanced Thoracoabdominal CT in Patients During Extracorporeal Membrane Oxygenation. Acad Radiol. 2021 Jan;28(1):58-67. doi: 10.1016/j.acra.2020.01.029. Epub 2020 Feb 21.

    PMID: 32094031BACKGROUND

  • Yang KJ, Wang CH, Huang YC, Tseng LJ, Chen YS, Yu HY. Clinical experience of whole-body computed tomography as the initial evaluation tool after extracorporeal cardiopulmonary resuscitation in patients of out-of-hospital cardiac arrest. Scand J Trauma Resusc Emerg Med. 2020 Jun 11;28(1):54. doi: 10.1186/s13049-020-00746-5.

    PMID: 32527321BACKGROUND

  • Zotzmann V, Rilinger J, Lang CN, Duerschmied D, Benk C, Bode C, Wengenmayer T, Staudacher DL. Early full-body computed tomography in patients after extracorporeal cardiopulmonary resuscitation (eCPR). Resuscitation. 2020 Jan 1;146:149-154. doi: 10.1016/j.resuscitation.2019.11.024. Epub 2019 Dec 4.

    PMID: 31811881BACKGROUND

  • Holmberg MJ, Geri G, Wiberg S, Guerguerian AM, Donnino MW, Nolan JP, Deakin CD, Andersen LW; International Liaison Committee on Resuscitation's (ILCOR) Advanced Life Support and Pediatric Task Forces. Extracorporeal cardiopulmonary resuscitation for cardiac arrest: A systematic review. Resuscitation. 2018 Oct;131:91-100. doi: 10.1016/j.resuscitation.2018.07.029. Epub 2018 Jul 29.

    PMID: 30063963BACKGROUND

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Dietmar Tamandl, MD, Assoc.-Prof.

    Medical University of Vienna

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, MD

Study Record Dates

First Submitted

February 21, 2022

First Posted

March 22, 2022

Study Start

February 1, 2022

Primary Completion

July 1, 2024

Study Completion

March 1, 2025

Last Updated

November 22, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)