Clinical trial NCT02344043: Cerebral Oxygenation and Neurological Outcomes FOllowing CriticAL Illness
Official title: Cerebral Oxygenation and Neurological Outcomes FOllowing CriticAL Illness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Sepsis
Delirium
Respiratory Failure
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2015-01-22
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is recruiting critically ill patients admitted to the 33-bed medical/surgical intensive care unit at an academic medical centre.

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Delirium
timeFrame: Proportion of ICU stay spent delirious. The average ICU stay is 7 days at our institution, however, some patients may stay much longer. We will perform delirium screening to a maximum of 30 days after ICU admission.
Secondary outcomes:
measure: Neurocognitive performance on KINARM tasks
timeFrame: 3 and 12 months
measure: Neurocognitive performance on the RBANS
timeFrame: 3 and 12 months
measure: Correlation between brain tissue oxygenation and physiological parameters
timeFrame: First 24 hours of admission
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
Study officials:
affiliation: Queen's University
name: John G Boyd, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Cerebral Oxygenation and Neurological Outcomes Following Critical Illness (CONFOCAL) Research Group; Canadian Critical Care Trials Group; Wood MD, Maslove DM, Muscedere JG, Day AG, Gordon Boyd J. Low brain tissue oxygenation contributes to the development of delirium in critically ill patients: A prospective observational study. J Crit Care. 2017 Oct;41:289-295. doi: 10.1016/j.jcrc.2017.06.009. Epub 2017 Jun 15.