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

NCT ID: NCT05847634

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-25

Study Completion Date

2026-01-31

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:

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.

Conditions

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ARDS, Human

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Acute Respiratory Distress Syndrome

Adults admitted to ICU with ARDS confirmed according to Berlin Definition

Masimo O3 NIRS cerebral oximetry and SedLine processed EEG

Intervention Type DEVICE

Non-invasive neuromonitoring device for observational study

Interventions

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Masimo O3 NIRS cerebral oximetry and SedLine processed EEG

Non-invasive neuromonitoring device for observational study

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Asher Mendelson

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Asher Mendelson, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

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Health Sciences Centre Winnipeg

Winnipeg, Manitoba, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Asher Mendelson, MD PhD

Role: CONTACT

Phone: 204-787-8059

Email: [email protected]

Facility Contacts

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Asher Mendelson, MD PhD

Role: primary

Other Identifiers

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HS25505

Identifier Type: -

Identifier Source: org_study_id