Recruiting

Observational Study

Sponsor:

University of Manitoba

Code:

NCT05847634

Conditions

ARDS, Human

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Masimo O3 NIRS cerebral oximetry and SedLine processed EEG

Study Details

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

Study ID

NCT05847634

Start date

Nov 25, 2024

Status verified date

Dec, 2024

Completion date

Jan, 2026

Anticipated

Primary completion date

Jan, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

Acute Respiratory Distress Syndrome

Adults admitted to ICU with ARDS confirmed according to Berlin Definition

Interventions

Masimo O3 NIRS cerebral oximetry and SedLine processed EEG

Non-invasive neuromonitoring device for observational study

Primary outcome measure

  • Recruitment [ Time Frame: 20 months ]
  • Data Quality [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

Asher Mendelson, MD PhD

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

Locations

Health Sciences Centre Winnipeg

Recruiting

Winnipeg, Manitoba, Canada, R3T2N2

Contacts

Asher Mendelson, MD PhD

2047878059asher.mendelson@umanitoba.ca

More Information

Sponsor

University of Manitoba

Last update posted

Dec 6, 2024

Last verified

Dec, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2024-12-06.