Cerebral Oxygenation and Neurological Outcomes FOllowing CriticAL Illness

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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A detailed protocol is currently under review for funding at Physician Services Incorporated, and can be included pending decision.

Conditions

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Critical Illness Sepsis Delirium Respiratory Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Critical illness

This prospective cohort of critically ill patients will have brain tissue oxygen levels recorded for 24 hours after admission with near infrared spectroscopy.

Near infrared spectroscopy

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Critically ill patients defined as having either:

1. Respiratory failure: Defined as invasive mechanical ventilation for a predicted duration of \>24 hours, or:
2. Shock: Defined as being on one of the following agents:
* norepinephrine (\>5 mcg/min) IV
* epinephrine (at any dose)
* vasopressin (in combination with another pressor)
* milrinone (in combination with another pressor)

Exclusion Criteria

* expected survival \<24 hours
* history of cognitive dysfunction
* unable to participate in follow up testing

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Dr. Gordon Boyd

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John G Boyd, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

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Kingston General Hospital

Kingston, Ontario, Canada

Site Status

Countries

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Canada

References

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Khan JM, Shore A, Lee KFH, Wood MD, Maslove DM, Hunt M, Georgescu I, Muscedere J, Boyd JG. Cerebral autoregulation-based mean arterial pressure targets and delirium in critically ill adults without brain injury: a retrospective cohort study. Can J Anaesth. 2024 Jan;71(1):107-117. doi: 10.1007/s12630-023-02609-w. Epub 2023 Nov 6.

Reference Type DERIVED

PMID: 37932650 (View on PubMed)

Wood MD, Jacobson JA, Maslove DM, Muscedere JG, Boyd JG; Cerebral Oxygenation and Neurological Outcomes Following Critical Illness (CONFOCAL) Research Group. The physiological determinants of near-infrared spectroscopy-derived regional cerebral oxygenation in critically ill adults. Intensive Care Med Exp. 2019 May 2;7(1):23. doi: 10.1186/s40635-019-0247-0.

Reference Type DERIVED

PMID: 31049754 (View on PubMed)

Wood MD, Maslove DM, Muscedere J, Scott SH, Boyd JG; Canadian Critical Care Trials Group. Robotic technology provides objective and quantifiable metrics of neurocognitive functioning in survivors of critical illness:A feasibility study. J Crit Care. 2018 Dec;48:228-236. doi: 10.1016/j.jcrc.2018.09.011. Epub 2018 Sep 12.

Reference Type DERIVED

PMID: 30243203 (View on PubMed)