Examining brain oxygen levels and neurological outcomes after critical illness

Cerebral Oxygenation and Neurological Outcomes FOllowing CriticAL Illness-2

This study tests if measuring brain oxygen levels can help understand how critical illness affects brain function and memory in patients after they recover.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Queen's University (Academic / other)
• Locations: 1 site (Kingston, Ontario)
• Trial ID: NCT03141619 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the relationship between cerebral oxygenation and neurological outcomes in patients who have experienced critical illness. Using near-infrared spectroscopy, the study measures brain tissue oxygenation as a non-invasive indicator of cerebral perfusion. It assesses acute neurological dysfunction through the presence of delirium and evaluates long-term cognitive impairments using robotic testing and neuropsychological assessments. The goal is to determine if poor cerebral perfusion is a risk factor for both immediate and lasting neurological issues in survivors.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 years old who are admitted to a critical care unit with respiratory failure requiring mechanical ventilation or experiencing shock.

Not a fit: Patients who have a life expectancy of less than 24 hours or those with central nervous system conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved monitoring and management strategies for patients recovering from critical illness, potentially reducing the incidence of neurological dysfunction.

How similar studies have performed: Other studies have explored cerebral oxygenation in critical illness, but this specific approach using near-infrared spectroscopy for long-term neurological outcomes is relatively novel.

Eligibility criteria

Inclusion

1. Adults ≥ 18 years old
2. Admitted to a critical care unit requiring one or more of the following:

   (a) Respiratory failure requiring invasive mechanical ventilation with an expected duration \>24 hours (b) Shock of any etiology. Shock is defined by the need for one of the following vasopressors/inotropes: (i) Dopamine ≥7.5 mcg/kg/min (ii) Dobutamine ≥5 mcg/kg/min (iii) Norepinephrine ≥5 mcg/min (iv) Phenylephrine ≥75 mcg/min (v) Epinephrine at any dose (vi) Milrinone at any dose (if used in conjunction with another agent) (vii) Vasopressin ≥0.03 u/min(if used in conjunction with another agent)

Exclusion:

1. Admission to the ICU \> 24 hours
2. Life expectancy \<24 hours
3. Admitting diagnosis that affects the central nervous system
4. Any reason that the subject may not be able to participate in the follow up assessments (i.e. limb amputation, paresis, neuromuscular disorders)

Where this trial is running

Kingston, Ontario

• Kingston General Hospital — Kingston, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: J. Gordon Boyd, MD, PhD — Queen's University
• Study coordinator: J. Gordon Boyd, MD, PhD

Conditions Critical Illness; Respiratory Failure; Shock; Delirium; cerebral oximetry; near-infrared spectroscopy; neurocognitive; post-ICU syndrome