Optimized CT-imaging Protocol in VA-ECMO Patients After CPR
NCT ID: NCT05290805
Last Updated: 2024-11-22
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
50 participants
INTERVENTIONAL
2022-02-01
2025-03-31
Brief Summary
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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.
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Detailed Description
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Extracorporal membrane oxygenation (ECMO) is an increasingly applied method of last resort for treating severe respiratory or combined cardiopulmonary failure. Different configurations of cannulation, either veno-venous (VV) or veno-arterial (VA), are used depending on indication. The latter is commonly used in patients under cardiopulmonary resuscitation to temporarily provide adequate organ-perfusion until the underlying pathology is found and treated. Alas being a revolutionary method, there is also a non-negligible number of vascular complications due to necessary insertion of cannulas in large vessels in combination with full anticoagulation. Therefore, these patients are regularly examined with a subsequent contrast-enhanced computed tomography to rule out complications and search for potential underlying causes of cardiac arrest. However, the extraordinary hemodynamic situation resulting from VA-cannulation with antegrade and retrograde perfusion challenges the diagnostically required simultaneous opacification of pulmonary and systemic arterial vessels. In this setting, siphoning, mixing and dilution effects of contrast agent and non-contrasted blood often cause incomplete or inhomogeneous vessel contrast, rendering exams partially non-diagnostic. Evidence regarding the effect of cannula position, ECMO flow rate, cardiac function and contrast agent injection site is scarce and as yet, to the best of the authors' knowledge, no standardized scan protocol for this patient collective exists.
Methods:
All adult emergency department patients at the Vienna General Hospital with femoro-femoral VA-ECMO and undergoing or recent cardiopulmonary resuscitation, who are subsequently referred to a clinically indicated CT scan for the detection of causes and complications or their exclusion, will be included in this study, aiming for a total of n=50 patients. The first 25 consecutive patients will be assigned to the intervention (flow reduction) cohort and the following 25 consecutive patients will be assigned to the control (no flow reduction) cohort. Clinical data (e.g. ECMO flow rate, ventilation parameters, cardiac function, venous line for contrast injection) at the time of imaging will be retrieved from the accompanying treating physician and are documented via a standardized data sheet.
In the intervention cohort ECMO flow rate is reduced for the duration of contrast administration and acquisition of an arterial and venous phase of the whole body (max. 1-2 minutes) given the hemodynamic and respiratory situation allows it. Whether this is possible, is determined right before the CT scan by the accompanying emergency physician and adapted to the individually tolerable level (max. 50% of initial flow, no less than 1,5 liter/min). After image acquisition, ECMO flow rate is then immediately returned to the initial or clinically optimal value at this moment. If the patient shows any signs of instability during this short period of imaging acquisition, the scan will be interrupted and immediate countermeasures will be taken by the accompanying team of emergency physicians and nurses. During the examination the vital signs of all patients are permanently monitored. The applied CT protocol is the established protocol at our department and 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, e.g. CT of cervical spine or CTA of cerebral arteries, will be performed as clinically indicated. After the examination, ECMO flow rate will be increased to the initial or at this point clinically optimal value and the acquired images are, within clinical routine, immediately reviewed and reported by the radiologist in charge. Diagnostic quality of the acquired images, vessel opacification, the impact of CT findings and diagnoses on clinical management as well as resulting management changes will be documented and analyzed.
Aims:
The aim of this single-center prospective cohort study is to evaluate the performance of an optimized CT protocol and whether a reduction of ECMO flow rate improves contrast enhancement of critically relevant vessels in CT examinations of patients after cardiopulmonary resuscitation with femoro-femoral VA-ECMO (eCPR) in comparison to a non-reduction cohort.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
DIAGNOSTIC
NONE
Study Groups
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ECMO flow rate reduction
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.
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.
no ECMO flow rate reduction
In this cohort ECMO flow rate is not reduced for CT image acquisition.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Clinically indicated CT and CT angiography of chest and abdomen (and head, if required)
* Femoro-femoral VA-ECMO-cannulation
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Philipp Dominik Stelzer
Principal Investigator, MD
Principal Investigators
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Dietmar Tamandl, MD, Assoc.-Prof.
Role: STUDY_DIRECTOR
Medical University of Vienna
Locations
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Medical University of Vienna
Vienna, Vienna, Austria
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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EK-Nr. 1941/2021
Identifier Type: -
Identifier Source: org_study_id
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