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

University of Manitoba

Status: Enrolling

Conditions: ARDS, Human

Treatments: Device: Masimo O3 NIRS cerebral oximetry and SedLine processed EEG

Study type: Observational

Funder types: Other

Identifiers

NCT05847634

HS25505

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 1 patient group

Acute Respiratory Distress Syndrome

Description:

Adults admitted to ICU with ARDS confirmed according to Berlin Definition

Treatment:

Device: Masimo O3 NIRS cerebral oximetry and SedLine processed EEG