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OpenTrials
Completed

NCT Number: NCT04472247

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Helsinki University Central Hospital, Department of Anesthesiology and Intensive Care, Helsinki, Uudenmaan Lääni, Finland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Continuous EEG and EMG monitoring, with derived variables

Diagnostic Test

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jul 15, 2020
Registry last updated
Jul 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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