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

NCT04472247 | Completed

• 1 other identifier: Responsiveness
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Electroencephalography; Critical Care; Electromyography

Outcome Measures

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.

  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

Study Arms (1)

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

Interventions

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.

Critical Care Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Postoperative patients, requiring postoperative critical care.

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Helsinki: lead

Study Sites (2)

Helsinki University Central Hospital, Department of Anesthesiology and Intensive Care

Helsinki, Uudenmaan Lääni, 00029, Finland

Location

Helsinki University Central Hospital, Department of Cardiac Surgery

Helsinki, Uudenmaan Lääni, 00029, Finland

Location

Related Publications (3)

• 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.

  PMID: 23269131 RESULT

• Ball J. How useful is the bispectral index in the management of ICU patients? Minerva Anestesiol. 2002 Apr;68(4):248-51.

  PMID: 12024092 RESULT

• 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.

  PMID: 15899745 RESULT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Juhani Stewart, MD

Study Record Dates

• First Submitted: July 11, 2020
• First Posted: July 15, 2020
• Study Start: May 7, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: July 15, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

FI (2)