NeuPaRT Study

Neurologic Physiology after Removal of Therapy study (NeuPaRT)

1. What is this study?

The purpose of this study is to determine when brain function stops compared to when the heart stops by monitoring electrical brain

activity in patients who are taken off life support and progress to death in the intensive care unit.

2. Why are we doing it?

There are many Canadians who need an organ transplant and who will never get one. In the past, people could only be organ donors

after being declared brain dead.

The dead donor rule serves this purpose by ensuring that death determination precedes organ retrieval. In Canada, death

determination occurs in one of two ways. In neurologic determination of death (NDD), death is declared upon completion of a

standardized neurologic assessment that confirms permanent loss of brain activity. In donation after death determination by circulatory criteria (DCC), death is declared 5 minutes after circulatory arrest. By confirming permanent loss of brain activity, the current NDD process

protects donors from suffering and maintains stakeholder trust. In contrast, the current DCC process assumes, but does not

explicitly confirm, permanent loss of brain activity when death is declared 5 minutes after circulatory arrest. While this assumption is

rooted in a strong physiologic rationale, lack of compelling evidence regarding cessation of brain activity in humans contributes to

ongoing mistrust of the DCC process among healthcare and public stakeholders.

3. Who is eligible (enrolment criteria)?

This study will enrol patients from the intensive care units at five participating academic centres:(LHSC, Foothills Medical Centre in Calgary, the Ottawa Hospital, Kingston Health Sciences Centre and the Centre Hospitalier de l'Université de Montréal) beginning in August 2022 for a duration of 3 years. We will approach the substitute decision maker of consecutive patients who are >18, have a consensual plan for WLSM in the intensive care unit, have an indwelling arterial cannula for monitoring arterial pulse pressure, and the attending physicians anticipate death within 24 hours of WLSM. Patients fulfilling criteria for death by neurological criteria or with injuries that anatomically preclude neuromonitoring will be excluded.

4. Study interventions

If a patient agrees to participate in the study, basic information, such as age, gender, diagnosis, and all the standard actions that happen as part of end of life care, such as medicines and medical procedures started and stopped, will be collected from the medical chart and recorded in a database. As well, once the patient's doctor and healthcare team start removing life support, a research coordinator will collect information from the machines that monitor your heart activity, blood pressure, breathing rate and brain activity. If the patient is eligible to be an organ donor they may still participate in this study. Participating in this study will not affect the process of organ donation. This information will be recorded at the central monitoring station and saved electronically and the information will be entered into a database on a password protected, secure website. During this process, you and the healthcare team will not see the information being collected and it will not interfere with your interaction with your family. After the doctor has declared death, we will continue to collect information from the monitors for 30 minutes. This does not change usual practice after death. Your family will be able to be with you throughout the dying process and there will be no restrictions on their activities at the bedside. 

Extra monitors that measure brain activity and function will be used. These include: 

1) a video-electroencephalogram (EEG), an electric tracing measuring brain waves; 

2) transcranial doppler ultrasound test (TCD) which involves placing two probes on the temples of the head which are held in place by a harness to passively examine blood flow in the brain; 

3) evoked potentials, a test used to measure brainstem function; or 

4) event-related potentials, a test designed to assess the possibility of conscious experience.  

Not every participant will have all 4 tests done. The patient will have a maximum of 2 of the 4 tests done depending on the circumstances at the time of testing. The study team will discuss this in detail with the patient or their substitute decision maker (SDM) before performing any tests as part of the study. 

Willing participants will also be asked to complete a form gathering information related to issues of equity, diversity and inclusion. Patients may decline to complete this form.  

5. Resources