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

Primary Purpose

Cardiopulmonary Arrest, VA-ECMO

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
ECMO flow rate reduction
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiopulmonary Arrest focused on measuring CPR, ECMO, Vessel opacification, Computed tomography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of ViennaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ECMO flow rate reduction

no ECMO flow rate reduction

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Subjective CT image quality
To assess whether flow reduction improves subjective CT image quality compared to the no-flow reduction cohort, measured by a Likert-Scale from 1-5.
CT vessel opacification homogeneity
To assess whether flow reduction results in a more homogeneous vessel opacification, measured by standard deviation of HU in a representative cross-section of clinically relevant vessels.
Follow-up CT exams
To assess whether an all-in-one exam before ICU admission reduces number of follow-up CT exams, radiation dose and/or contrast agent dose, measured by comparing cumulative exam numbers, radiation and contrast agent dose of the study cohort to a retrospective cohort of eCPR exams.
Correlations between mean vessel opacification, subjective image quality and appearance of artifacts with intrinsic and extrinsic factors
To find correlations between intrinsic and extrinsic factors and mean vessel opacification, subjective image quality and appearance of artifacts, measured by correlation of mean HU for metric variables and uni- and multivariate analysis for binary variables.

Full Information

First Posted
February 21, 2022
Last Updated
March 14, 2023
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT05290805
Brief Title
Optimized CT-imaging Protocol in VA-ECMO Patients After CPR
Official Title
Optimized CT-imaging Protocol in VA-ECMO Patients After Cardiopulmonary Resuscitation - a Single-center Prospective Non-randomized Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Background: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiopulmonary Arrest, VA-ECMO
Keywords
CPR, ECMO, Vessel opacification, Computed tomography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ECMO flow rate reduction
Arm Type
Experimental
Arm Description
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.
Arm Title
no ECMO flow rate reduction
Arm Type
No Intervention
Arm Description
In this cohort ECMO flow rate is not reduced for CT image acquisition.
Intervention Type
Diagnostic Test
Intervention Name(s)
ECMO flow rate reduction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Computed tomography vessel opacification
Description
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.
Time Frame
Three years
Title
Number and clinical impact of pathological findings
Description
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.
Time Frame
ten days
Secondary Outcome Measure Information:
Title
Subjective CT image quality
Description
To assess whether flow reduction improves subjective CT image quality compared to the no-flow reduction cohort, measured by a Likert-Scale from 1-5.
Time Frame
Three years
Title
CT vessel opacification homogeneity
Description
To assess whether flow reduction results in a more homogeneous vessel opacification, measured by standard deviation of HU in a representative cross-section of clinically relevant vessels.
Time Frame
Three years
Title
Follow-up CT exams
Description
To assess whether an all-in-one exam before ICU admission reduces number of follow-up CT exams, radiation dose and/or contrast agent dose, measured by comparing cumulative exam numbers, radiation and contrast agent dose of the study cohort to a retrospective cohort of eCPR exams.
Time Frame
Three years
Title
Correlations between mean vessel opacification, subjective image quality and appearance of artifacts with intrinsic and extrinsic factors
Description
To find correlations between intrinsic and extrinsic factors and mean vessel opacification, subjective image quality and appearance of artifacts, measured by correlation of mean HU for metric variables and uni- and multivariate analysis for binary variables.
Time Frame
Three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philipp Stelzer, MD
Phone
+43 (0)1 40400
Ext
48180
Email
philipp.d.stelzer@meduniwien.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Dietmar Tamandl, MD, Assoc.-Prof.
Phone
+43 (0)1 40400
Ext
48180
Email
dietmar.tamandl@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dietmar Tamandl, MD, Assoc.-Prof.
Organizational Affiliation
Medical University of Vienna
Official's Role
Study Director
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philipp Stelzer, MD
Phone
+43 (0)1 40400
Ext
48180
Email
philipp.d.stelzer@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Dietmar Tamandl, MD
Phone
+43 (0)1 40400
Ext
48180
Email
dietmar.tamandl@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Christian Wassipaul, MD
First Name & Middle Initial & Last Name & Degree
Michael Arnoldner, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27799498
Citation
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.
Results Reference
background
PubMed Identifier
24183316
Citation
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.
Results Reference
background
PubMed Identifier
23257678
Citation
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.
Results Reference
background
PubMed Identifier
25296619
Citation
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.
Results Reference
background
PubMed Identifier
28057636
Citation
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.
Results Reference
background
PubMed Identifier
32094031
Citation
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.
Results Reference
background
PubMed Identifier
32527321
Citation
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.
Results Reference
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PubMed Identifier
31811881
Citation
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.
Results Reference
background
PubMed Identifier
30063963
Citation
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.
Results Reference
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Optimized CT-imaging Protocol in VA-ECMO Patients After CPR

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