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Spectral Edge Frequency From Spectral EEG Analysis to Guide Deep Sedation in the Critical Care Setting (Pilot)

Use of Spectral Analysis of Electroencephalographic Activity to Guide Deep Sedoanalgesia and Its Effect on Propofol Consumption in Patients Hospitalized in the Intensive Care Unit: a Pilot Study

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04026451
Acronym
SEFICU
Enrollment
0
Registered
2019-07-19
Start date
2019-11-11
Completion date
2021-04-01
Last updated
2022-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Sedation, Mechanical Ventilation

Keywords

Sedation, EEG, Mechanical Ventilation, Critical Care, Propofol

Brief summary

Critically ill patients under mechanical ventilation (MV) have pain, anxiety, sleep deprivation and agitation. The use of analgesics and sedatives drugs (sedoanalgesia) is a common practice to produce pain relief and comfort during the VM. Despite its usefulness, it has been documented that the excessive use of sedatives is associated with an increased risk of prolonging the stay under MV and in the Intensive Care Unit (ICU). To avoid this, current evidence suggests the use of protocols guided to clinical goals, such as the sedation-agitation scale (SAS), or daily suspension of infusions to avoid excess sedation. These protocols minimize the prescription of deep sedation, which is still necessary for 20-30% of patients. Monitoring of sedation with electroencephalography in the ICU has been underutilized. In fact, only the use of indices that are generated from algorithms of the electroencephalographic signal processing has been reported. However, it has been shown that the use of these monitoring systems does not benefit the heterogeneous groups of patients in MV. Currently, the clinical monitors used to measure the effect of drugs used in a sedoanalgesia show in the screen the spectrogram of the brain electrical signal and quantify the frequency under which 95% of the electroencephalographic power is located, known as spectral edge frequency 95 (SEF95). This value in a person who is conscious is usually greater than 20 Hz, in a patient undergoing general anesthesia it is between 10 and 15 Hz. In preliminary measurements, in deeply sedated patients in the ICU, SEF95 values are under 5 Hz. This would indicate that patients in the ICU are being overdosed. It is unknown if in cases with an indication of deep sedation, the use of monitoring by spectrogram is superior to the standard management guided at clinical scales, such as SAS. Therefore, the investigators propose the following hypothesis: In patients with an appropriate indication of deep sedation (SAS 1-2), the sedoanalgesia guided by the spectral edge frequency 95 reduces the consumption of propofol compared to the deep sedoanalgesia guided by the sedation scale agitation in MV patients in the ICU maintaining a clinically adequate level of sedation.

Detailed description

To determine whether deep sedoanalgesia guided by the spectral edge frequency 95 decreases propofol consumption with respect to deep sedoanalgesia guided by the sedation-agitation scale in patients hospitalized in the Intensive Care Unit under mechanical ventilation. * Group intervention: sedation will be guided by SEF95 and SAS. Patients will be sedated to keep a SAS 1-2 with a SEF95 between 10 to 13 Hz. * Group control: sedation will be guided by SAS. However, SEF95 will be also recorded but covered.

Interventions

DEVICESedation guided by SEF95 (10-13 Hz) from SedLine® monitor

Dosage of propofol and fentanyl will be guided by SEF95 value between 10-13 Hz. If SEF95 is lower than 10 Hz, the infusion rate of propofol and fentanyl will be diminished; if SEF95 is higher than 13 Hz, the infusion rate of propofol and fentanyl will be increased; and if SEF95 is between 10-13 Hz, then the infusion rate will be kept.

BEHAVIORALSedation guided by SAS scale (1-2)

Dosage of propofol and fentanyl will be guided by SAS to keep a value of 1-2. If SAS is higher than 1-2, then the infusion rate of propofol and fentanyl will be increased; and if SAS is 1-2, then the infusion rate of propofol and fentanyl will be maintained.

DRUGDeep sedation with propofol andfentanyl

Propofol and fentanyl will be infused to reach a score in the SAS of 1-2

PROCEDUREMechanical Ventilation

Critically ill patients will be ventilated mechanically following the clinical indication.

Sponsors

University of Chile
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Older than 18 years * Indication of deep sedation with propofol and fentanyl for more than 48 h

Exclusion criteria

* Brain damage * Cognitive impairment * Allergy to propofol or fentanyl * Limitation of therapeutic effort * Liver chronic disease Child C * Prone positioning and use of neuromuscular blocking agents

Design outcomes

Primary

MeasureTime frameDescription
Plasma concentration of propofol48 hoursIt will be measured using HPLC

Secondary

MeasureTime frameDescription
Total dose of fentanylEach 2 hours for 48 hoursIn mcg
SAS (Sedation Agitation Scale)Each 2 hours for 48 hoursThe scale evaluates sedation and agitation of a patient, thus the name is Sedation Agitation Scale. The total range goes from 1 to 7, where: 1 is Unarousable, 2 is Very Sedated, 3 is Sedated, 4 is Calm and Cooperative, 5 is Agitated, 6 is Very Agitated, and 7 is Dangerous Agitation. If clinical indication is a deep sedation, then the patient must reach a SAS 1-2. If clinical indication is a light sedation, then the patient must reach a SAS 3-4. Scores of 5, 6 and 7 must be avoided with drugs.
SEF95Each 2 hours for 48 hoursSpectral Edge Frequency 95
Mean Arterial PressureEach 2 hours for 48 hoursIn mmHg
Plasma triglyceride levels24 hours and 48 hoursCentral laboratory
Total dose of propofolEach 2 hours for 48 hoursIn mg
Duration of mechanical ventilationUp to 30 daysSince the beginning of the protocol
Stay in intensive unit careUp to 30 daysSince the beginning of the protocol
Wake up after stopping the infusion of propofolUp to 48 hours
DeliriumUp to 10 daysEvaluated with CAM-ICU twice a day during the stay in ICU
Plasma lactate concentration24 hours and 48 hoursCentral laboratory

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026