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.

Study Overview

• Status: Completed
• Conditions: Critical Care; Electroencephalography; Electromyography
• Intervention / Treatment: Diagnostic test: Continuous EEG and EMG monitoring, with derived variables

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Finland
  • Uudenmaan Lääni
    • Helsinki, Uudenmaan Lääni, Finland, 00029
      • Helsinki University Central Hospital, Department of Anesthesiology and Intensive Care
    • Helsinki, Uudenmaan Lääni, Finland, 00029
      • Helsinki University Central Hospital, Department of Cardiac Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Postoperative patients, requiring postoperative critical care.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Critical Care Patients; 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).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EEG and EMG variables correlate with the level of sedation (as measured by the established RASS score), and are reactive with nociceptive stimulation.	Noninvasive neuromonitoring variables are collected and analysed against the RASS score, which quantifies patient's sedation level.	2 (1-3) days from admission to ICU

Collaborators and Investigators

• Sponsor: University of Helsinki

Publications and helpful links

General Publications

• Barr J, Fraser GL, Puntillo K, Ely EW, Gelinas C, Dasta JF, Davidson JE, Devlin JW, Kress JP, Joffe AM, Coursin DB, Herr DL, Tung A, Robinson BR, Fontaine DK, Ramsay MA, Riker RR, Sessler CN, Pun B, Skrobik Y, Jaeschke R; American College of Critical Care Medicine. Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit. Crit Care Med. 2013 Jan;41(1):263-306. doi: 10.1097/CCM.0b013e3182783b72.
• Ball J. How useful is the bispectral index in the management of ICU patients? Minerva Anestesiol. 2002 Apr;68(4):248-51.
• Fraser GL, Riker RR. Bispectral index monitoring in the intensive care unit provides more signal than noise. Pharmacotherapy. 2005 May;25(5 Pt 2):19S-27S. doi: 10.1592/phco.2005.25.5_part_2.19s.

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2007
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: July 11, 2020
• First Submitted That Met QC Criteria: July 11, 2020
• First Posted (Actual): July 15, 2020

Study Record Updates

• Last Update Posted (Actual): July 15, 2020
• Last Update Submitted That Met QC Criteria: July 11, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Responsiveness

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No