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
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
Affiliations
Charles Weijer
Department of Philosophy, Western University, London, Ontario, Canada
Loretta Norton
Department of Psychology, King’s University College at Western University, London, Ontario, Canada
Teneille Gofton
Department of Clinical Neurological Sciences, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada
Marat Slessarev
Department of Medicine, University of Western Ontario, London, Ontario, Canada
Michaël Chasse
Department of Medicine, Université de Montréal, Montreal, Québec, Canada
John Gordon Boyd
Department of Medicine, Division of Neurology, Queen’s University, Kingston, Ontario, Canada
Frédérick D'Aragon
Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada
Shane English
Division of Critical Care, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada
Maureen Meade
Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada
Sam Shemie
Pediatric Intensive Care, McGill University, Montreal, Québec, Canada
Sonny Dhanani
Department of Pediatrics, Division of Critical Care, Children’s Hospital of Eastern Ontario and University of Ottawa, Ottawa, Ontario, Canada
Andreas H Kramer
Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
Jennifer Chandler
Law, University of Ottawa, Ottawa, Ontario, Canada
Eileen Campbell
Department of Medicine, London Health Sciences Centre, London, Ontario, Canada
Jeffrey Singh
Interdepartmental Division of Critical Care Medicine, University of Toronto Faculty of Medicine, Toronto, Ontario, Canada
Yun-Hee Choi
2 Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, University of Western Ontario, London, Ontario, Canada
Maxwell J Smith
Faculty of Health Sciences, University of Western Ontario, London, Ontario, Canada
Erika Chamberlain
Faculty of Law, Western University, London, Ontario, Canada
Nathan B Scales
Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
Nicholas Murphy
Philosophy and Medicine, Western University, London, Ontario, Canada
Derek Debicki
Department of Clinical Neurological Sciences, Western University, London, Ontario, Canada
Tadeu A Fantaneanu
Department of Medicine, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
Julie Kromm
Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
Tracey C Bentall
Department of Medicine, London Health Sciences Centre, London, Ontario, Canada
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.
