Recruiting

Observational Study

Sponsor:

Dr. Gordon Boyd

Code:

NCT03141619

Conditions

Critical Illness

Respiratory Failure

Shock

Delirium

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This study is designed to test the hypothesis that poor cerebral perfusion during critical illness is a risk factor for acute and long-term neurological dysfunction among survivors. We use near-infrared spectroscopy to measure brain tissue oxygenation as a non-invasive surrogate marker for cerebral perfusion. Acute neurological dysfunction is defined as the presence of delirium, which is assessed using the Confusion Assessment Method-Intensive Care Unit (CAM-ICU). Chronic neurological dysfunction is defined as having quantitative impairments on robotic testing (KINARM robot) and traditional neuropsychological screening (Repeatable Battery for the Assessment of Neuropsychological Status).

Conditions

Critical Illness

Respiratory Failure

Shock

Delirium

Study ID

NCT03141619

Start date

Oct 13, 2017

Status verified date

Dec, 2023

Completion date

Jun, 2025

Anticipated

Primary completion date

Jun, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Respiratory failure and/or shock

All enrolled patients will undergo 72 hours of monitoring of cerebral oxygenation with near-infrared spectroscopy.

Primary outcome measure

  • Regional cerebral oxygenation (rSO2) and delirium [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Locations

Kingston General Hospital

Recruiting

Kingston, Ontario, Canada, K7L3V7

Contacts

John G Boyd, MD, PhD

613-549-66662jgb1@queensu.ca

More Information

Sponsor

Dr. Gordon Boyd

Last update posted

Dec 26, 2023

Last verified

Dec, 2023

Keywords

  • cerebral oximetry
  • near-infrared spectroscopy
  • neurocognitive
  • post-ICU syndrome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. Gordon Boyd on 2023-12-26.