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Clinical Trials/NCT04472247
NCT04472247
Completed
Not Applicable

Sedation Monitoring Using Frontal Electroencephalogram, Electromyogram and Hemodynamic Responses to Pain in Critical Care

University of Helsinki2 sites in 1 country30 target enrollmentMay 7, 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Electroencephalography
Sponsor
University of Helsinki
Enrollment
30
Locations
2
Primary Endpoint
EEG and EMG variables correlate with the level of sedation (as measured by the established RASS score), and are reactive with nociceptive stimulation.
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Purpose: Assessing nociception and sedation in mechanically ventilated patients in the ICU is challenging, with few reliable methods available for continuous monitoring. Measurable cardiovascular and neurophysiological variables, such as blood pressure, heart rate, frontal EEG, and frontal EMG, might provide a medium for sedation and nociception monitoring. The hypothesis of this explorative study is that the aforementioned variables correlate with the level of sedation, as described by the Richmond Agitation-Sedation score (RASS).

Methods: Thirty adult postoperative ICU patients on mechanical ventilation and receiving intravenous sedation, excluding patients with primary neurological disorders, head injury, or need for continuous neuromuscular blockage. Continuous measurements of bispectral index (BIS), EMG power (EMG), EMG-derived Responsiveness Index (RI), averaged blood pressure variability (ARV), and Surgical Pleth Index (SPI) were tested against repeated RASS measurements, and separately against responsiveness to painful stimuli at varying RASS levels.

Registry
clinicaltrials.gov
Start Date
May 7, 2007
End Date
April 1, 2009
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Juhani Akseli Stewart

Dr. Juhani Stewart, MD

University of Helsinki

Eligibility Criteria

Inclusion Criteria

  • Adult patients (over 18 years old)
  • Postoperative ICU admission (planned and un-planned admissions), on mechanical ventilation via an endotracheal tube, with invasive hemodynamic monitoring via an arterial line
  • receiving intravenous sedation by continuous infusion (propofol, midazolam).

Exclusion Criteria

  • primary neurological disorders (including stroke, cardiac arrest with probable hypoxic brain injury, intracranial hemorrhage, and head injury with reduced level of consciousness prior to intubation), the continuous use of neuromuscular blocking agents during monitoring, confirmed meningitis or encephalitis, or a short data collection time (less than 12 hours).

Outcomes

Primary Outcomes

EEG and EMG variables correlate with the level of sedation (as measured by the established RASS score), and are reactive with nociceptive stimulation.

Time Frame: 2 (1-3) days from admission to ICU

Noninvasive neuromonitoring variables are collected and analysed against the RASS score, which quantifies patient's sedation level.

Study Sites (2)

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