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

NCT04472247 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2020-07-15

No results posted yet for this study

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

  • Electroencephalography
  • Critical Care
  • Electromyography

Interventions

DIAGNOSTIC_TEST

Continuous EEG and EMG monitoring, with derived variables

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

Sponsors & Collaborators

  • University of Helsinki

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-07
Primary Completion
2009-04-01
Completion
2009-04-01

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04472247 on ClinicalTrials.gov