Clinical Trials Directory

Trials / Completed

CompletedNCT04472247

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

Status
Completed
Phase
Study type
Observational
Enrollment
30 (actual)
Sponsor
University of Helsinki · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTContinuous EEG and EMG monitoring, with derived variablesAll patients are monitored during their ICU stay by frontal EEG and EMG measuring devides, which are already in clinical use.

Timeline

Start date
2007-05-07
Primary completion
2009-04-01
Completion
2009-04-01
First posted
2020-07-15
Last updated
2020-07-15

Locations

2 sites across 1 country: Finland

Source: ClinicalTrials.gov record NCT04472247. Inclusion in this directory is not an endorsement.