ARDS, Human
Conditions
Keywords
Near-Infrared Spectroscopy, Depth of Sedation, Intensive Care Unit, Electroencephalography, Acute Respiratory Distress Syndrome
Brief summary
Investigation of the feasibility of monitoring processed transcutaneous electroencephalography (EEG), a method of interpreting brain activity, and near-infrared spectroscopy (NIRS), a method of determining levels of tissue oxygenation (StO2) in the brain, for patients with acute respiratory distress syndrome (ARDS) in the ICU.
Detailed description
The aim of this study is to determine the feasibility of using Masimo SedLine processed EEG monitoring and Masimo O3 NIRS to monitor optimal depth of sedation for patients with ARDS in the ICU. To achieve this, non-invasive devices will be applied to the participant to measure processed EEG signal and StO2. Cerebrovascular reactivity will be determined using the following two values: 1. SEDopt: The optimal depth of sedation that minimizes correlation between StO2 and processed EEG monitoring. 2. MAPopt: The optimal blood pressure that minimizes correlation between StO2 and MAP. Demographic information (age, sex, height, weight), past medical history, etiology of ARDS, Disease severity, routine bloodwork, and dose of sedation will also be documented.
Interventions
DEVICEMasimo O3 NIRS cerebral oximetry and SedLine processed EEG
Non-invasive neuromonitoring device for observational study
Sponsors
University of Manitoba
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patient admitted to the ICU * ARDS confirmed according to the Berlin Definition * Invasive mechanical ventilation * Deep sedation and/or neuromuscular blockade required for ARDS treatment at the discretion of the treating medical team * Application of monitoring devices feasible
Exclusion criteria
* More than 24 hours elapsed since ICU admission * Death is deemed imminent and inevitable during the next 24 hours * Known allergy to a textile component of the device * Consent declined from patient or authorized third party * The treating clinician believes that participation in the study would not be in the best interest of the patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment | 20 months | Recruitment of two patients per month, allowing for seasonal variation in ARDS. |
| Data Quality | 7 days | Physiologic signal with greater than 80% data quality to allow for calculation of SEDopt |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SEDopt | 7 days | Optimal depth of sedation that minimizes correlation between tissue oxygenation (StO2) and total hemoglobin (THb) as measure by O3 NIRS and processed EEG monitoring as defined by SedLine PSi. |
| MAPopt | 7 days | Optimal depth of sedation that minimizes correlation between tissue oxygenation (StO2) and mean arterial pressure as measured by invasive arterial line. |
Countries
Canada
Contacts
Primary ContactAsher Mendelson, MD PhD
Outcome results
None listed