Menu
Recruiting NCT05847634

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

— Observational ARDS, Human

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Masimo O3 NIRS cerebral oximetry and SedLine processed EEG.
Who it may be relevant to
Registry conditions: ARDS, Human. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

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.

Interventions

  • Device Masimo O3 NIRS cerebral oximetry and SedLine processed EEG
    Non-invasive neuromonitoring device for observational study

Primary outcome measures

  • Recruitment [Time frame: 20 months]
  • Data Quality [Time frame: 7 days]
Secondary outcome measures (2)
  • SEDopt [Time frame: 7 days]
  • MAPopt [Time frame: 7 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Canada · 1 center
  • Health Sciences Centre Winnipeg — Winnipeg

Identifiers

NCT: NCT05847634 · HS25505

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗