CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Continuous EEG and EMG monitoring, with derived variablesother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04472247
NCT04472247N/ACompleted

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

University of Helsinki·observational·Posted Jul 15, 2020·Updated Jul 15, 2020

In Brief

An observational study evaluating Continuous EEG and EMG monitoring, with derived variables for Electroencephalography and 2 related conditions. Completed, enrolled 30 participants across 2 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesFinland
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 15, 2020
Enrollment StartMay 7, 2007
Primary CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 6.0 years ago

Interventions

Continuous EEG and EMG monitoring, with derived variablesother

All patients are monitored during their ICU stay by frontal EEG and EMG measuring devides, which are already in clinical use.