Sepsis Clinical Trial
Official title:
Cerebral Oxygenation and Neurological Outcomes FOllowing CriticAL Illness
Purpose of the Study Critical illness requiring life support affects over 150 000 people in
Ontario every year. With aggressive support, the number of people who die from critical
illness is decreasing. However, people who survive often have neurological problems. These
neurological problems often include difficulties with memory, concentration, and attention.
These problems are associated with poor quality of life among survivors of critical illness.
The aim of this study is to identify the factors that contribute to these neurological
deficits. Specifically, the investigators are testing whether changes in oxygen delivery to
the brain during critical illness are related to both short- and long-term neurological
complications.
Procedures involved in the Research When patients are diagnosed with a critical illness such
as shock or respiratory failure, they are treated with intravenous fluids, medications to
raise their blood pressure, and can be placed on a ventilator to assist with their
breathing. They are observed in an intensive care unit (ICU). This research protocol does
NOT interfere with the normal treatment of patients with critical illness. The procedure
involved in this research protocol requires the placement of two stickers to either side of
the patient's forehead, and information about oxygen delivery to the brain will be recorded.
When the patient has recovered from the critical illness, they will be asked to perform
several neurological tests. Some of these tests will be done with a pencil and paper, while
others will use a robotic device to test arm movements, reaction time, and concentration.
Potential Harms, Risks or Discomforts:
This research study involves the placement of a sticker sensor to either side of the
forehead. Rarely, patients may develop a rash to these electrodes. The investigators monitor
patients very carefully for rashes, and if a rash is to occur, the sticker sensor will be
removed. With regards to the neurological testing, rarely patients can have some mild muscle
stiffness after moving their arms in the robot. The investigators do not expect any other
further harms, risks, or discomforts.
A detailed protocol is currently under review for funding at Physician Services Incorporated, and can be included pending decision. ;
Observational Model: Cohort, Time Perspective: Prospective
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