Neurologic Physiology after Removal of Therapy (NeuPaRT) study: study protocol of a multicentre, prospective, observational, pilot feasibility study of neurophysiology after withdrawal of life-sustaining measures
Introduction In donation after circulatory determination of death, death is declared 5 min after circulatory arrest. This practice assumes, but does not explicitly confirm, permanent loss of brain activity. While this assumption is rooted a strong physiological rationale, paucity of direct human dat...
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BMJ Publishing Group
2023-04-01
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| author | Charles Weijer Loretta Norton Teneille Gofton Marat Slessarev Michaël Chasse John Gordon Boyd Frédérick D'Aragon Shane English Maureen Meade Sam Shemie Sonny Dhanani Andreas H Kramer Jennifer Chandler Eileen Campbell Jeffrey Singh Yun-Hee Choi Maxwell J Smith Erika Chamberlain Nathan B Scales Nicholas Murphy Derek Debicki Tadeu A Fantaneanu Julie Kromm Tracey C Bentall |
| author_facet | Charles Weijer Loretta Norton Teneille Gofton Marat Slessarev Michaël Chasse John Gordon Boyd Frédérick D'Aragon Shane English Maureen Meade Sam Shemie Sonny Dhanani Andreas H Kramer Jennifer Chandler Eileen Campbell Jeffrey Singh Yun-Hee Choi Maxwell J Smith Erika Chamberlain Nathan B Scales Nicholas Murphy Derek Debicki Tadeu A Fantaneanu Julie Kromm Tracey C Bentall |
| author_sort | Charles Weijer |
| collection | DOAJ |
| description | Introduction In donation after circulatory determination of death, death is declared 5 min after circulatory arrest. This practice assumes, but does not explicitly confirm, permanent loss of brain activity. While this assumption is rooted a strong physiological rationale, paucity of direct human data regarding temporal relationship between cessation of brain activity and circulatory arrest during the dying process threatens public and healthcare provider trust in deceased organ donation.Methods and analysis In this cohort study, we will prospectively record cerebral and brainstem electrical activity, cerebral blood flow velocity and arterial blood pressure using electroencephalography (EEG), brainstem evoked potentials, transcranial doppler and bedside haemodynamic monitors in adult patients undergoing planned withdrawal of life sustaining measures in the intensive care units at five hospital sites for 18 months. We will use MATLAB to synchronise waveform data and compute the time of cessation of each signal relative to circulatory arrest. Our primary outcome is the feasibility of patient accrual, while secondary outcomes are (a) proportion of patients with complete waveform recordings and data transfer to coordinating site and (b) time difference between cessation of neurophysiological signals and circulatory arrest. We expect to accrue 1 patient/site/month for a total of 90 patients.Ethics and dissemination We have ethics approval from Clinical Trials Ontario (protocol #3862, version 1.0, date 19 January 2022.) and the relevant Research Ethics Board for each site. We will obtain written informed consent from legal substitute decision makers. We will present study results at research conferences including donor family partner forum and in peer-reviewed publications.Trial registration number NCT05306327. |
| format | Article |
| id | doaj-art-a52f80cfa80a47258d986aeed2940013 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2023-04-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-a52f80cfa80a47258d986aeed29400132025-08-20T02:12:31ZengBMJ Publishing GroupBMJ Open2044-60552023-04-0113410.1136/bmjopen-2023-073643Neurologic Physiology after Removal of Therapy (NeuPaRT) study: study protocol of a multicentre, prospective, observational, pilot feasibility study of neurophysiology after withdrawal of life-sustaining measuresCharles Weijer0Loretta Norton1Teneille Gofton2Marat Slessarev3Michaël Chasse4John Gordon Boyd5Frédérick D'Aragon6Shane English7Maureen Meade8Sam Shemie9Sonny Dhanani10Andreas H Kramer11Jennifer Chandler12Eileen Campbell13Jeffrey Singh14Yun-Hee Choi15Maxwell J Smith16Erika Chamberlain17Nathan B Scales18Nicholas Murphy19Derek Debicki20Tadeu A Fantaneanu21Julie Kromm22Tracey C Bentall23Department of Philosophy, Western University, London, Ontario, CanadaDepartment of Psychology, King’s University College at Western University, London, Ontario, CanadaDepartment of Clinical Neurological Sciences, Schulich School of Medicine and Dentistry, Western University, London, Ontario, CanadaDepartment of Medicine, University of Western Ontario, London, Ontario, CanadaDepartment of Medicine, Université de Montréal, Montreal, Québec, CanadaDepartment of Medicine, Division of Neurology, Queen’s University, Kingston, Ontario, CanadaCentre de Recherche du Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, CanadaDivision of Critical Care, Department of Medicine, University of Ottawa, Ottawa, Ontario, CanadaDepartment of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, CanadaPediatric Intensive Care, McGill University, Montreal, Québec, CanadaDepartment of Pediatrics, Division of Critical Care, Children’s Hospital of Eastern Ontario and University of Ottawa, Ottawa, Ontario, CanadaCumming School of Medicine, University of Calgary, Calgary, Alberta, CanadaLaw, University of Ottawa, Ottawa, Ontario, CanadaDepartment of Medicine, London Health Sciences Centre, London, Ontario, CanadaInterdepartmental Division of Critical Care Medicine, University of Toronto Faculty of Medicine, Toronto, Ontario, Canada2 Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, University of Western Ontario, London, Ontario, CanadaFaculty of Health Sciences, University of Western Ontario, London, Ontario, CanadaFaculty of Law, Western University, London, Ontario, CanadaOttawa Hospital Research Institute, Ottawa, Ontario, CanadaPhilosophy and Medicine, Western University, London, Ontario, CanadaDepartment of Clinical Neurological Sciences, Western University, London, Ontario, CanadaDepartment of Medicine, Ottawa Hospital Research Institute, Ottawa, Ontario, CanadaCumming School of Medicine, University of Calgary, Calgary, Alberta, CanadaDepartment of Medicine, London Health Sciences Centre, London, Ontario, CanadaIntroduction In donation after circulatory determination of death, death is declared 5 min after circulatory arrest. This practice assumes, but does not explicitly confirm, permanent loss of brain activity. While this assumption is rooted a strong physiological rationale, paucity of direct human data regarding temporal relationship between cessation of brain activity and circulatory arrest during the dying process threatens public and healthcare provider trust in deceased organ donation.Methods and analysis In this cohort study, we will prospectively record cerebral and brainstem electrical activity, cerebral blood flow velocity and arterial blood pressure using electroencephalography (EEG), brainstem evoked potentials, transcranial doppler and bedside haemodynamic monitors in adult patients undergoing planned withdrawal of life sustaining measures in the intensive care units at five hospital sites for 18 months. We will use MATLAB to synchronise waveform data and compute the time of cessation of each signal relative to circulatory arrest. Our primary outcome is the feasibility of patient accrual, while secondary outcomes are (a) proportion of patients with complete waveform recordings and data transfer to coordinating site and (b) time difference between cessation of neurophysiological signals and circulatory arrest. We expect to accrue 1 patient/site/month for a total of 90 patients.Ethics and dissemination We have ethics approval from Clinical Trials Ontario (protocol #3862, version 1.0, date 19 January 2022.) and the relevant Research Ethics Board for each site. We will obtain written informed consent from legal substitute decision makers. We will present study results at research conferences including donor family partner forum and in peer-reviewed publications.Trial registration number NCT05306327.https://bmjopen.bmj.com/content/13/4/e073643.full |
| spellingShingle | Charles Weijer Loretta Norton Teneille Gofton Marat Slessarev Michaël Chasse John Gordon Boyd Frédérick D'Aragon Shane English Maureen Meade Sam Shemie Sonny Dhanani Andreas H Kramer Jennifer Chandler Eileen Campbell Jeffrey Singh Yun-Hee Choi Maxwell J Smith Erika Chamberlain Nathan B Scales Nicholas Murphy Derek Debicki Tadeu A Fantaneanu Julie Kromm Tracey C Bentall Neurologic Physiology after Removal of Therapy (NeuPaRT) study: study protocol of a multicentre, prospective, observational, pilot feasibility study of neurophysiology after withdrawal of life-sustaining measures BMJ Open |
| title | Neurologic Physiology after Removal of Therapy (NeuPaRT) study: study protocol of a multicentre, prospective, observational, pilot feasibility study of neurophysiology after withdrawal of life-sustaining measures |
| title_full | Neurologic Physiology after Removal of Therapy (NeuPaRT) study: study protocol of a multicentre, prospective, observational, pilot feasibility study of neurophysiology after withdrawal of life-sustaining measures |
| title_fullStr | Neurologic Physiology after Removal of Therapy (NeuPaRT) study: study protocol of a multicentre, prospective, observational, pilot feasibility study of neurophysiology after withdrawal of life-sustaining measures |
| title_full_unstemmed | Neurologic Physiology after Removal of Therapy (NeuPaRT) study: study protocol of a multicentre, prospective, observational, pilot feasibility study of neurophysiology after withdrawal of life-sustaining measures |
| title_short | Neurologic Physiology after Removal of Therapy (NeuPaRT) study: study protocol of a multicentre, prospective, observational, pilot feasibility study of neurophysiology after withdrawal of life-sustaining measures |
| title_sort | neurologic physiology after removal of therapy neupart study study protocol of a multicentre prospective observational pilot feasibility study of neurophysiology after withdrawal of life sustaining measures |
| url | https://bmjopen.bmj.com/content/13/4/e073643.full |
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