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Cerebral Oxygenation and Neurological Outcomes FOllowing CriticAL Illness

NCT02344043 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 116

Last updated 2016-11-28

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Near infrared spectroscopy

This device uses near infrared spectroscopy to measure tissue oxygen levels (0-100%). The sensors are placed on the subjects' forehead to measure brain tissue oxygenation

Sponsors & Collaborators

  • Queen's University

    lead OTHER

Principal Investigators

  • John G Boyd, MD, PhD · Queen's University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02344043 on ClinicalTrials.gov