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NCT Number: NCT05847634

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Health Sciences Centre Winnipeg

Winnipeg, Manitoba, R3T2N2, Canada

Location status: Recruiting

Location contact

Asher Mendelson, MD PhD

CONTACT

[email protected]

2047878059

About this study

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:

  • SEDopt: The optimal depth of sedation that minimizes correlation between StO2 and processed EEG monitoring.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Masimo O3 NIRS cerebral oximetry and SedLine processed EEG

Device

Non-invasive neuromonitoring device for observational study

Primary outcomes

  1. Recruitment

    Time frame: 20 months

    Recruitment of two patients per month, allowing for seasonal variation in ARDS.

  2. Data Quality

    Time frame: 7 days

    Physiologic signal with greater than 80% data quality to allow for calculation of SEDopt

Secondary outcomes

  1. SEDopt

    Time frame: 7 days

    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.

  2. MAPopt

    Time frame: 7 days

    Optimal depth of sedation that minimizes correlation between tissue oxygenation (StO2) and mean arterial pressure as measured by invasive arterial line.

Study contacts

Contact information is provided by the study sponsor or research team.

Asher Mendelson, MD PhD

CONTACT

[email protected]

204-787-8059

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 6, 2023
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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