About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Adults admitted to the ICU with ARDS
Trial design
Cohort
Prospective
Treatments tested in this trial
Masimo O3 NIRS cerebral oximetry and SedLine processed EEG
DeviceNon-invasive neuromonitoring device for observational study
Treatment groups
Trial outcomes
Primary outcomes
Recruitment
Recruitment of two patients per month, allowing for seasonal variation in ARDS.
Data Quality
Physiologic signal with greater than 80% data quality to allow for calculation of SEDopt
Secondary outcomes
SEDopt
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
Optimal depth of sedation that minimizes correlation between tissue oxygenation (StO2) and mean arterial pressure as measured by invasive arterial line.
Sponsors and contacts
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