What will happen during this study?

information about the study interventions and answers to frequently asked questions

How many people will take part in this study?

It is anticipated that about 108 people will take part in this study, from hospitals located in Ontario, Quebec and Alberta.

This study should take three years to complete and the results should be known in about 4 years from the start of the study (study start = January 2022).

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.

Video-EEG

EEG will be used to measure the electrical activity of the brain. The purpose of the video-EEG is to eliminate artifact caused by movements in the room from the study data. The video will be focused only on the bed and will not include other parts of the room. The patient's family will not be directly recorded. However, if their hand enters the area of the bed then it will be recorded in the video. No other part of them will be recorded unless it is directly within the area of the bed. Sound will not be recorded. The video will only be seen by the researchers reviewing the EEG data and it will only be used for the purpose of eliminating artifact (EEG artifacts are signals seen in the EEG that do not come from the brain. These come from movement in the area around the EEG or from other nearby equipment) from the data and to make sure that all waveforms seen are truly from the brain.

Transcranial Doppler Ultrasound

Transcranial doppler ultrasound, or TCD, is used to measure blood flow to the brain. A small ultrasound probe is placed gently on the temple and this probe is held in place by a round frame. The TCD is not painful.

Evoked and Event-Related Potentials

For eligible participants, tests called evoked and event-related potentials may be used to measure electrical activity in the brainstem and a test called event-related potentials may be used to measure consciousness during the study. Evoked and event-related potentials are used to measure the brain’s response to external stimulation (e.g., sounds, sensation to external stimulus) but event-related potentials can also be used to measure cognitive functions that we think reflect conscious awareness. Both of these tests involve the use of small detectors placed on the skin or scalp to record electrical activity in the brain and the brainstem. A sound or sensory stimulus is provided and then brain electrical activity is recorded using a limited number of electrodes similar to those used to record the EEG. These tests require the study team to present a small stimulus (either a low volume sound using an earphone in one ear or a small sensory stimulus at the wrist) in order to look for any response in the brain. For the purposes of this study, evoked and event-related potentials will provide additional information about how the brain is processing external stimuli at the time of the test. The evoked and event-related potential tests are being done only at London Health Sciences Centre.

Data Management

The researchers will collect information about patients from their medical charts and monitoring equipment and enter this information into an electronic database. The data will be securely stored, and will be maintained by the study doctor and the Lawson Health Research Institute. The database can only be accessed by people who are involved in research.

How long will participants be in the study?

Participation on this study will last for about less than 24 hours. Monitoring will take place for 10 minutes before the life sustaining measures are removed and will last until 30 minutes after the heart stops.

Can participants choose to leave the study?

Participant will have additional wires connected to them. If they do not agree with this once they see it then they may ask for the monitoring to be stopped and withdraw from the study. Withdrawal from the study will not affect the care that the patient or their loved one receives while at the hospital.

A patient can choose to end their participation in this research (called withdrawal) at any time without having to provide a reason.

A patient may withdraw their permission to use information that was collected about them for this study at any time by letting the research team know. However, this would also mean that they withdraw from the study.

If participant decides to leave the study, they can ask that the information that was collected about them not be used for the study.

Can participation in the study end early?

Participation on the study may be stopped early, and without participant's consent, for reasons such as:

If recording lasts longer than 24 hours before the heart stops
The research team decides to stop the study
The research ethics board withdraws permission for this study to continue

What are the risks or harms of participating in this study?

There are no medical risks to a participant from participating in this study, but taking part in this study may make their family uncomfortable. We realize that this is a very stressful time for the patient and their family and we will provide whatever support they may need, such as the use of palliative care, social service, pastoral services, etc, throughout the study process to address the family’s concerns and to help them cope.

What are the benefits of participating in this study?

Participants and their families may not receive direct benefit from participating in this study. We hope the information learned from this study will help to make organ donation processes even better in the future.

How will participant information be kept confidential?

The research team will only collect the information they need for this study. Records identifying participants at the study center will be kept confidential and, to the extent permitted by applicable laws, will not be disclosed or made publicly available, except as described in this consent document.

Authorized representatives of the following organizations may look at your original (identifiable) medical records at the site where these records are held, to check that the information collected for the study is correct and follows proper laws and guidelines:

Representatives from the trials’ coordinating center – London Health Sciences Centre, Drs. Gofton and Slessarev, and the research team at London Health Sciences Centre.
The research ethics board that oversees the ethical conduct of this study in Ontario.
The enrolling and affiliated sites, to oversee the conduct of research at the enrolling site.
The Quality Assurance and Education Officers from Lawson Health Research Institute (Lawson) may audit this research study for quality assurance purposes.

Information that is collected about participants for the study (called study data) may also be sent to the organizations listed above. Representatives of Clinical Trials Ontario, a not-for-profit organization, may see study data that is sent to the research ethics board for this study. Participants' names, addresses, emails, or other information that may directly identify them will not be used. The records received by these organizations may contain participants' codes, initials, sex, and dates of birth.

This study requires the transfer of identifiable information to Drs. Gofton and Slessarev at London Health Sciences Centre for the purpose of compiling the data from all study sites. The following information will be transferred: participant code, sex, and age.

If the results of this study are published, participants' identities will remain confidential. It is expected that the information collected during this study will be used in analyses, presented to the scientific community at meetings, and published in journals.

Even though the likelihood that someone may identify participants from the study data is very small, it can never be completely eliminated.

A copy of the consent form that participants or their SDM sign to enter the study may be included in the participant's health record/hospital chart.

What are the right of participants in a reseach study?

Participants will be informed, in a timely manner, about any new information that may be relevant to their willingness to stay in this study. Participants have the right to be informed of the results of this study once the entire study is complete.

Participants' rights to privacy are legally protected by federal and provincial laws that require safeguards to ensure that their privacy is respected. By signing the informed consent form (ICF), participants do not give up any of their legal rights against the study doctors, sponsor, or involved institutions for compensation, nor does the ICF relieve the study doctor, sponsor, or their agents of their legal and professional responsibilities.

Participant will be given a copy of the signed and dated informed consent form prior to participating in this study.

Whom do participants contact for questions?

If you have questions about taking part in this study, or if you suffer a research-related injury, you can talk to the research team, or the person who is in charge of the study at this institution. That person is: Dr. Teneille Gofton, tel. 519-685-8500, ext. 32911

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