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

Completed

• Conditions: Electroencephalography; Critical Care; Electromyography
• Interventions: Diagnostic Test: Continuous EEG and EMG monitoring, with derived variables

• Registration Number: NCT04472247
• Lead Sponsor: University of Helsinki

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-07
• Primary Completion: 2009-04-01
• Study Completion: 2009-04-01
• Status Verified: 2020-07
• Study First Submitted: 2020-07-11
• Study First Submitted QC: 2020-07-11
• Last Update Submitted: 2020-07-11
• Study First Posted: 2020-07-15
• Last Update Posted: 2020-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Critical Care Patients	Continuous EEG and EMG monitoring, with derived variables	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).

Primary Outcome Measures

Name	Time	Method
EEG and EMG variables correlate with the level of sedation (as measured by the established RASS score), and are reactive with nociceptive stimulation.	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.

Trial Locations

Locations (2)

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

Helsinki University Central Hospital, Department of Cardiac Surgery; 🇫🇮 Helsinki, Uudenmaan Lääni, Finland