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

Teneille Gofton; Sonny Dhanani; Maureen Meade; John Gordon Boyd; Erika Chamberlain; Jennifer Chandler; Michaël Chassé; Nathan B Scales; Yun-Hee Choi; Frédérick D'Aragon; Derek Debicki; Shane English; Tadeu A Fantaneanu; Andreas H Kramer; Julie Kromm; Nicholas Murphy; Loretta Norton; Jeffrey Singh; Maxwell J Smith; Charles Weijer; Sam Shemie; Tracey C Bentall; Eileen Campbell; Marat Slessarev

doi:10.1136/bmjopen-2023-073643

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. 2023 Apr 27;13(4):e073643. doi: 10.1136/bmjopen-2023-073643.

Authors

Teneille Gofton¹, Sonny Dhanani², Maureen Meade³, John Gordon Boyd⁴, Erika Chamberlain⁵, Jennifer Chandler⁶, Michaël Chassé⁷, Nathan B Scales⁸, Yun-Hee Choi⁹, Frédérick D'Aragon^{10

11}, Derek Debicki¹², Shane English^{13

14}, Tadeu A Fantaneanu¹⁵, Andreas H Kramer¹⁶, Julie Kromm¹⁶, Nicholas Murphy¹⁷, Loretta Norton¹⁸, Jeffrey Singh^{19

20}, Maxwell J Smith²¹, Charles Weijer²², Sam Shemie²³, Tracey C Bentall²⁴, Eileen Campbell²⁴, Marat Slessarev²⁵

Affiliations

¹ Department of Clinical Neurological Sciences, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada teneille.gofton@lhsc.on.ca.
² Pediatric Critical Care, Department of Pediatrics, University of Ottawa, Ottawa, Ontario, Canada.
³ Critical Care, McMaster University, Hamilton, Ontario, Canada.
⁴ Departments of Neurology and Critical Care, Queen's University, Kingston, Ontario, Canada.
⁵ Faculty of Law, Western University, London, Ontario, Canada.
⁶ Faculty of Law, University of Ottawa, Ottawa, Ontario, Canada.
⁷ Department of Medicine, Centre Hospitalier de Montréal, Montréal, Québec, Canada.
⁸ Dynamical Analysis Laboratory, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
⁹ Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.
¹⁰ Department of Anesthesiology, Universite de Sherbrooke Faculte de medecine et des sciences de la sante, Sherbrooke, Quebec, Canada.
¹¹ Centre de recherche du CHUS, Sherbrooke, Quebec, Canada.
¹² Department of Clinical Neurological Sciences, Western University, London, Ontario, Canada.
¹³ Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
¹⁴ Division of Critical Care, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
¹⁵ Department of Medicine, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
¹⁶ Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
¹⁷ Philosophy and Medicine, Western University, London, Ontario, Canada.
¹⁸ Department of Psychology, King's University College at Western University, London, Ontario, Canada.
¹⁹ Interdepartmental Division of Critical Care Medicine, University of Toronto Faculty of Medicine, Toronto, Ontario, Canada.
²⁰ Critical Care, University of Toronto, Toronto, Ontario, Canada.
²¹ School of Health Studies, Faculty of Health Sciences and Rotman Institute of Philosophy, Western University, London, ON, Canada.
²² Department of Philosophy, Western University, London, Ontario, Canada.
²³ Pediatric Intensive Care, McGill University, Montreal, Québec, Canada.
²⁴ Department of Medicine, London Health Sciences Centre, London, Ontario, Canada.
²⁵ Department of Medicine, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.

Abstract

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.

Keywords: adult intensive & critical care; neurology; neurophysiology.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Cohort Studies
Feasibility Studies
Heart Arrest*
Humans
Intensive Care Units
Multicenter Studies as Topic
Neurophysiology*
Observational Studies as Topic
Prospective Studies

Associated data

ClinicalTrials.gov/NCT05306327