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

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.

Study Overview

• Status: Recruiting
• Conditions: ARDS, Human
• Intervention / Treatment: Device: Masimo O3 NIRS cerebral oximetry and SedLine processed EEG

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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Asher Mendelson, MD PhD; Phone Number: 204-787-8059; Email: asher.mendelson@umanitoba.ca

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3T2N2
      • Recruiting
      • Health Sciences Centre Winnipeg
      • Contact: Asher Mendelson, MD PhD; Phone Number: 2047878059; Email: asher.mendelson@umanitoba.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults admitted to the ICU with ARDS

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Manitoba
• Investigators: Principal Investigator: Asher Mendelson, MD PhD, University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: April 27, 2023
• First Submitted That Met QC Criteria: April 27, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Intensive Care Unit; Acute Respiratory Distress Syndrome; Electroencephalography; Near-Infrared Spectroscopy; Depth of Sedation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: HS25505

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No