Actively Recruiting
Depth of Sedation and Its Impact on Cerebrovascular Reactivity in Acute Respiratory Distress Syndrome: a Pilot Analysis
Led by University of Manitoba · Updated on 2024-12-06
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how feasible it is to monitor brain activity and tissue oxygen levels in patients with acute respiratory distress syndrome (ARDS) in the intensive care unit (ICU). This study focuses on using processed transcutaneous electroencephalography (EEG) and near-infrared spectroscopy (NIRS) to better understand sedation depth and cerebrovascular reactivity in these patients. The goal is to improve monitoring techniques by assessing the relationship between brain oxygenation and sedation or blood pressure levels. Participants will have non-invasive devices called Masimo SedLine processed EEG and Masimo O3 NIRS applied to measure brain activity and tissue oxygenation (StO2). The study will determine the optimal depth of sedation (SEDopt) and optimal blood pressure (MAPopt) that minimize the correlation between these measurements. Along with monitoring, demographic details, medical history, disease severity, routine blood tests, and sedation doses will also be recorded. During the study, participants will be closely monitored in the ICU for up to 7 days to collect data on sedation depth and blood pressure effects on brain oxygenation. Researchers will review recruitment progress over 20 months and assess data quality within the first week. This observational study involves continuous monitoring and documentation to understand sedation impacts on cerebrovascular function in ARDS patients, with no investigational treatments administered.
CONDITIONS
Brief Title
Depth of Sedation and Its Impact on Cerebrovascular Reactivity in Acute Respiratory Distress Syndrome: a Pilot Analysis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 days
Participants have non-invasive neuromonitoring devices applied to measure processed EEG signals and cerebral oxygen saturation to assess sedation depth and cerebrovascular reactivity while in the ICU.
Continuous monitoring during ICU stay
Trial Site Locations
Total: 1 location
1
Health Sciences Centre Winnipeg
Winnipeg, Manitoba, Canada, R3T2N2
Actively Recruiting
Research Team
A
Asher Mendelson, MD PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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