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

U

University of Helsinki

Status

Completed

Conditions

Critical Care
Electroencephalography
Electromyography

Treatments

Diagnostic Test: Continuous EEG and EMG monitoring, with derived variables

Study type

Observational

Funder types

Other

Identifiers

NCT04472247
Responsiveness

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

30 participants in 1 patient group

Critical Care Patients
Description:
Critical care patients requiring mechanical ventilation via an endotracheal tube, with invasive hemodynamic monitoring via an arterial line, and receiving intravenous sedation by continuous infusion (propofol, midazolam).
Treatment:
Diagnostic Test: Continuous EEG and EMG monitoring, with derived variables

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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