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

Critical Care Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04472247
• Other study ID #: Responsiveness
• Status: Completed
• Start date: May 7, 2007
• Est. completion date: April 1, 2009

Study information

• Verified date: July 2020
• Source: University of Helsinki
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 1, 2009
• Est. primary completion date: April 1, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Critical Care
• Electroencephalography
• Electromyography

Intervention

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.

Locations

Country	Name	City	State
Finland	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

Sponsors (1)

Lead Sponsor	Collaborator
University of Helsinki

Country where clinical trial is conducted

Finland, 

References & Publications (3)

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

Barr J, Fraser GL, Puntillo K, Ely EW, Gélinas 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 — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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