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

NCT05847634 | Recruiting

• 1 other identifier: HS25505
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

ARDS, Human

Keywords

Near-Infrared Spectroscopy; Depth of Sedation; Intensive Care Unit; Electroencephalography; Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• SEDopt

  7 days

• MAPopt

  7 days

Study Arms (1)

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

Interventions

Masimo O3 NIRS cerebral oximetry and SedLine processed EEG DEVICE

Non-invasive neuromonitoring device for observational study

Acute Respiratory Distress Syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults admitted to the ICU with ARDS

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Health Sciences Centre Winnipeg

Winnipeg, Manitoba, R3T2N2, Canada

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Asher Mendelson, MD PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asher Mendelson, MD PhD

CONTACT

204-787-8059; asher.mendelson@umanitoba.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 6, 2023
• Study Start: November 25, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)