Depth of Sedation and Its Impact on Cerebrovascular Reactivity in Acute Respiratory Distress Syndrome: A Pilot Analysis

Study Overview
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Brief Summary
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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
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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: SEDopt: The optimal depth of sedation that minimizes correlation between StO2 and processed EEG monitoring. 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.

Official Title
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Depth of Sedation and Its Impact on Cerebrovascular Reactivity in Acute Respiratory Distress Syndrome: A Pilot Analysis

Conditions
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ARDS, Human

Intervention / Treatment
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* Device: Masimo O3 NIRS cerebral oximetry and SedLine processed EEG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute Respiratory Distress Syndrome<br>Adults admitted to ICU with ARDS confirmed according to Berlin Definition | Device: Masimo O3 NIRS cerebral oximetry and SedLine processed EEG<br>* Non-invasive neuromonitoring device for observational study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment | Recruitment of two patients per month, allowing for seasonal variation in ARDS. | 20 months | 
| Data Quality | Physiologic signal with greater than 80% data quality to allow for calculation of SEDopt | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 7 days | 
| MAPopt | Optimal depth of sedation that minimizes correlation between tissue oxygenation (StO2) and mean arterial pressure as measured by invasive arterial line. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Near-Infrared Spectroscopy, Depth of Sedation, Intensive Care Unit, Electroencephalography, Acute Respiratory Distress Syndrome