ElectroencephalographyNCT04472247
Sedation Monitoring Using Frontal Electroencephalogram, Electromyogram and Hemodynamic Responses to Pain in Critical Care
An observational study of Electroencephalography and Critical Care, run by University of Helsinki at 2 sites in Finland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Electroencephalography, Critical Care, Electromyography
- What is being tested?
- Continuous EEG and EMG monitoring, with derived variables
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 2 sitesFinland
- Study dates
- 7 May 2007to 1 Apr 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Postoperative patients, requiring postoperative critical care.
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Finland2 sites
Helsinki University Central Hospital, Department of Anesthesiology and Intensive Care
Helsinki, Uudenmaan Lääni, 00029
Helsinki University Central Hospital, Department of Cardiac Surgery
Helsinki, Uudenmaan Lääni, 00029
About this study
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
- Being tested
- Continuous EEG and EMG monitoring, with derived variables
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous EEG and EMG monitoring, with derived variablesDiagnostic test
All patients are monitored during their ICU stay by frontal EEG and EMG measuring devides, which are already in clinical use.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: Continuous EEG and EMG monitoring, with derived variables |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 (1-3) days from admission to ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start7 May 2007
- Primary completion1 Apr 2009
- Study completion1 Apr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ElectroencephalographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juhani Akseli Stewart, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472247
- Sponsor's protocol ID
- Responsiveness
- Status last verified
- Jul 2020
- First submitted
- 11 Jul 2020
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 23269131Ball J. How useful is the bispectral index in the management of ICU patients? Minerva Anestesiol. 2002 Apr;68(4):248-51.
PubMed 12024092Fraser 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.
PubMed 15899745
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedation Monitoring Using Frontal Electroencephalogram, Electromyogram and Hemodynamic Responses to Pain in Critical Care
- ClinicalTrials.gov ID
- NCT04472247
- Acronym / sponsor ID
- Responsiveness
- Conditions
- Electroencephalography, Critical Care, Electromyography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Study start
- 7 May 2007 (actual)
- Primary completion
- 1 Apr 2009 (actual)
- Study completion
- 1 Apr 2009 (actual)
- First posted
- 15 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critical Care Patients | – | Diagnostic Test: Continuous EEG and EMG monitoring, with derived variablesCritical 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Postoperative patients, requiring postoperative critical care.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous EEG and EMG monitoring, with derived variablesAll patients are monitored during their ICU stay by frontal EEG and EMG measuring devides, which are already in clinical use. | Diagnostic test | Critical Care Patients |
Primary outcome
EEG and EMG variables correlate with the level of sedation (as measured by the established RASS score), and are reactive with nociceptive stimulation.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Results publication: PubMed 23269131Barr 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.
- Results publication: PubMed 12024092Ball J. How useful is the bispectral index in the management of ICU patients? Minerva Anestesiol. 2002 Apr;68(4):248-51.
- Results publication: PubMed 15899745Fraser 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Electroencephalography and Critical Care, run by University of Helsinki at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG and EMG variables correlate with the level of sedation (as measured by the established RASS score), and are reactive with nociceptive stimulation. (time frame: 2 (1-3) days from admission to ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04472247, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020.