CT-Perfusion for Neurological Diagnostic Evaluation: Study update of a prospective multicenter diagnostic test study
CCCF ePoster library. Chassé M. 11/11/19; 283456; EP21
Michaël Chassé
Michaël Chassé
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Abstract
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ePoster
Topic: Clinical Trial

Chassé, M1,2, Carvalho, LP2; English, SW3,4; Fergusson. DA4,5; D'Aragon, F6,7; Couillard P8; Hannouche M9; Turgeon AF10,11; Lauzier F10,11,12; Haj-Moustafa A2; Guilbert F2; Boyd F13; Wang HT1; Ball I14; Shahin J15; Singh J16,17; Kutsogiannis J18; Burns K19; Meade M20; Slessarev M21; Marsolais P22; Green R23; Dhanani S24; Darvesh S25;  Zarychanski R26; Gibson A27; Binnie A28; Shankar J29 on behalf of the Canadian Critical Care Trials Group.
 
1 Department of Medicine, Critical Care, Université de Montréal, Montreal, QC, Canada;
2 Centre Hospitalier de l'Université de Montréal (CHUM) Research Center, Montreal, QC, Canada;
3 Department of Medicine (Critical Care), University of Ottawa, Ottawa, ON, Canada;
4 Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada;
5 Department of Medicine, University of Ottawa, Ottawa, ON, Canada;
6 Department of Anaesthesiology, Université de Sherbrooke, Sherbrooke, QC, Canada;
7 Centre de Recherche du CHU de Sherbrooke, Sherbrooke, QC, Canada;
8 Department of Critical Care Medicine, University of Calgary, Cumming School of Medicine, Alberta Health Services, Calgary, AB;
9 Department of Medicine, McGill University, Montreal, QC, Canada;
10 Department of Anesthesiology and Critical Care, Division of Critical Care Medicine, Université Laval, Québec City, QC, Canada;
11 Population Health and Optimal Health Practices Unit/Trauma-Emergency-Critical Care Medicine, CHU de Québec-Université Laval Research Center, Québec City, QC, Canada;
12 Department of Medicine, Université Laval, Québec City, QC, Canada;
13 Department of Critical Care, Queen's University, Kingston, ON, Canada;
14 Division of Critical Care Medicine and Department of Epidemiology and Biostatistics, Western University, Critical Care Trauma Centre, London Health Sciences Centre, London, ON, Canada
15 Department of Critical Care, Respiratory Division, McGill University, Montreal, QC, Canada;
16 Division of Critical Care Medicine, University Health Network, Toronto, ON, Canada;
17 Interdepartmental Division of Critical Care Medicine, Department of Medicine, University of Toronto, Toronto, ON, Canada;
18 Division of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada;
19 Interdepartmental Division of Critical Care, St Michael's Hospital, Toronto, ON, Canada;
20 Institute for Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada;
21 Department of Medicine, Western University, London, ON, Canada;
22 Hôpital du Sacré-Coeur de Montréal, Service de soins intensifs, Département de Médecine, and Centre de recherche Hôpital du Sacré-Cœur de Montréal, Université de Montréal, Montréal, QC, Canada;
23 Department of Critical Care, Dalhousie University, Halifax, NS, Canada;
24 Department of Critical Care, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa, ON, Canada;
25 Department of Medical Neuroscience, Department of Medicine (Neurology and Geriatric Medicine), Dalhousie University, Halifax, NS, Canada;
26 Department of Medicine, University of Manitoba, Winnipeg, MB, Canada;
27Department of Medicine and Family Medicine, McMaster University, Hamilton, ON, Canada;
28William Osler Health System, Hamilton, ON, Canada;
29 Department of Radiology, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, MB, Canada.


Introduction: Neurological determination of death (NDD) raises diagnostic challenges for practicing clinicians. Clinical confounders (e.g. use of sedatives, traumatic injuries or therapeutic hypothermia), can render NDD via clinical exam, which is the current reference standard, impossible. In such scenarios, neuroimaging ancillary tests are invaluable for diagnosing neurological death. Currently, there is no clear standard among ancillary tests for NDD and their use varies widely according to physician and hospital setting. Most ancillary tests of neurological death were evaluated for their ability to detect false positives (sensitivity) but not for their ability to detect false negatives (specificity). Computed Tomography Perfusion (CTP) imaging test is theoretically ideal, providing information about both brain blood flow and brain perfusion; however, its accuracy is yet to be determined.

Objectives: To establish the diagnostic accuracy of CTP to identify neurologic death. Secondary objectives are to 1) confirm the safety of performing CTP in critically ill patients suspected of neurological death; 2) establish the CTP inter-rater reliability in identifying NDD; and 3) compare the diagnostic accuracy of CTP, CT-Angiography, and clinical evaluation for NDD.

Methods: In an ongoing prospective Canadian multicentre cohort study at 12 hospitals in 5 provinces, we plan to enrol 300 adults (age over 18 years) with severe brain injury characterized by a Glasgow Coma Scale score of 3 without sedation for 6 hours. We exclude those with contraindications to CTP, any confounding factors precluding a complete neurological examination, or due to technical or logistical obstacles. Study patients are recruited with informed consent from substitute decision-makers (SDMs) or deferred consent, according to legal and regulatory requirement. A CTP is completed followed by a complete clinical NDD assessment by 2 physicians shortly after (within 2 hours). Clinicians are blinded to the CTP result. Principal analysis of primary outcome measure will include true negative, true positive, false negative and false positive measures, along with corresponding 95%CI, for CTP when compared to the reference standard. Only patients that completed the full clinical evaluation and CTP will be included in the primary analysis.Trial registration number-NCT03098511.

Preliminary results: From April 2017 to June 2019, we have screened 441 patients, and enrolled 160 at an average rate of 1 patient per month per site. Reasons for non-enrolment have included: 27 patients did not meet inclusion criteria; 151 had one or more exclusion criteria (123 for clinical reasons and 28 for logistical or technical reasons); 32 SDMs declined, and for 71 patients SDMs were not approached. The anticipated end of patient enrollment is late spring 2020.

Conclusion:  Our study will determine the diagnostic accuracy of CTP and determine if it is safe and reliable, therefore improving the accuracy of neurological death declaration. A more robust process may also foster our society's trust in the NDD process. Current progress in this study supports the feasibility of multicentre research to establish standards of care in the diagnosis of neurologic death.


No references

ePoster
Topic: Clinical Trial

Chassé, M1,2, Carvalho, LP2; English, SW3,4; Fergusson. DA4,5; D'Aragon, F6,7; Couillard P8; Hannouche M9; Turgeon AF10,11; Lauzier F10,11,12; Haj-Moustafa A2; Guilbert F2; Boyd F13; Wang HT1; Ball I14; Shahin J15; Singh J16,17; Kutsogiannis J18; Burns K19; Meade M20; Slessarev M21; Marsolais P22; Green R23; Dhanani S24; Darvesh S25;  Zarychanski R26; Gibson A27; Binnie A28; Shankar J29 on behalf of the Canadian Critical Care Trials Group.
 
1 Department of Medicine, Critical Care, Université de Montréal, Montreal, QC, Canada;
2 Centre Hospitalier de l'Université de Montréal (CHUM) Research Center, Montreal, QC, Canada;
3 Department of Medicine (Critical Care), University of Ottawa, Ottawa, ON, Canada;
4 Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada;
5 Department of Medicine, University of Ottawa, Ottawa, ON, Canada;
6 Department of Anaesthesiology, Université de Sherbrooke, Sherbrooke, QC, Canada;
7 Centre de Recherche du CHU de Sherbrooke, Sherbrooke, QC, Canada;
8 Department of Critical Care Medicine, University of Calgary, Cumming School of Medicine, Alberta Health Services, Calgary, AB;
9 Department of Medicine, McGill University, Montreal, QC, Canada;
10 Department of Anesthesiology and Critical Care, Division of Critical Care Medicine, Université Laval, Québec City, QC, Canada;
11 Population Health and Optimal Health Practices Unit/Trauma-Emergency-Critical Care Medicine, CHU de Québec-Université Laval Research Center, Québec City, QC, Canada;
12 Department of Medicine, Université Laval, Québec City, QC, Canada;
13 Department of Critical Care, Queen's University, Kingston, ON, Canada;
14 Division of Critical Care Medicine and Department of Epidemiology and Biostatistics, Western University, Critical Care Trauma Centre, London Health Sciences Centre, London, ON, Canada
15 Department of Critical Care, Respiratory Division, McGill University, Montreal, QC, Canada;
16 Division of Critical Care Medicine, University Health Network, Toronto, ON, Canada;
17 Interdepartmental Division of Critical Care Medicine, Department of Medicine, University of Toronto, Toronto, ON, Canada;
18 Division of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada;
19 Interdepartmental Division of Critical Care, St Michael's Hospital, Toronto, ON, Canada;
20 Institute for Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada;
21 Department of Medicine, Western University, London, ON, Canada;
22 Hôpital du Sacré-Coeur de Montréal, Service de soins intensifs, Département de Médecine, and Centre de recherche Hôpital du Sacré-Cœur de Montréal, Université de Montréal, Montréal, QC, Canada;
23 Department of Critical Care, Dalhousie University, Halifax, NS, Canada;
24 Department of Critical Care, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa, ON, Canada;
25 Department of Medical Neuroscience, Department of Medicine (Neurology and Geriatric Medicine), Dalhousie University, Halifax, NS, Canada;
26 Department of Medicine, University of Manitoba, Winnipeg, MB, Canada;
27Department of Medicine and Family Medicine, McMaster University, Hamilton, ON, Canada;
28William Osler Health System, Hamilton, ON, Canada;
29 Department of Radiology, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, MB, Canada.


Introduction: Neurological determination of death (NDD) raises diagnostic challenges for practicing clinicians. Clinical confounders (e.g. use of sedatives, traumatic injuries or therapeutic hypothermia), can render NDD via clinical exam, which is the current reference standard, impossible. In such scenarios, neuroimaging ancillary tests are invaluable for diagnosing neurological death. Currently, there is no clear standard among ancillary tests for NDD and their use varies widely according to physician and hospital setting. Most ancillary tests of neurological death were evaluated for their ability to detect false positives (sensitivity) but not for their ability to detect false negatives (specificity). Computed Tomography Perfusion (CTP) imaging test is theoretically ideal, providing information about both brain blood flow and brain perfusion; however, its accuracy is yet to be determined.

Objectives: To establish the diagnostic accuracy of CTP to identify neurologic death. Secondary objectives are to 1) confirm the safety of performing CTP in critically ill patients suspected of neurological death; 2) establish the CTP inter-rater reliability in identifying NDD; and 3) compare the diagnostic accuracy of CTP, CT-Angiography, and clinical evaluation for NDD.

Methods: In an ongoing prospective Canadian multicentre cohort study at 12 hospitals in 5 provinces, we plan to enrol 300 adults (age over 18 years) with severe brain injury characterized by a Glasgow Coma Scale score of 3 without sedation for 6 hours. We exclude those with contraindications to CTP, any confounding factors precluding a complete neurological examination, or due to technical or logistical obstacles. Study patients are recruited with informed consent from substitute decision-makers (SDMs) or deferred consent, according to legal and regulatory requirement. A CTP is completed followed by a complete clinical NDD assessment by 2 physicians shortly after (within 2 hours). Clinicians are blinded to the CTP result. Principal analysis of primary outcome measure will include true negative, true positive, false negative and false positive measures, along with corresponding 95%CI, for CTP when compared to the reference standard. Only patients that completed the full clinical evaluation and CTP will be included in the primary analysis.Trial registration number-NCT03098511.

Preliminary results: From April 2017 to June 2019, we have screened 441 patients, and enrolled 160 at an average rate of 1 patient per month per site. Reasons for non-enrolment have included: 27 patients did not meet inclusion criteria; 151 had one or more exclusion criteria (123 for clinical reasons and 28 for logistical or technical reasons); 32 SDMs declined, and for 71 patients SDMs were not approached. The anticipated end of patient enrollment is late spring 2020.

Conclusion:  Our study will determine the diagnostic accuracy of CTP and determine if it is safe and reliable, therefore improving the accuracy of neurological death declaration. A more robust process may also foster our society's trust in the NDD process. Current progress in this study supports the feasibility of multicentre research to establish standards of care in the diagnosis of neurologic death.


No references

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