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

November 2, 2022 updated by: Antonello Penna, University of Chile

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

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.

Study Overview

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • RM
      • Santiago, RM, Chile, 7690306
        • Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile
      • Santiago, RM, Chile, 7690306
        • Hospital Clinico de la Universidad de Chile

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Critical care patients with an indication of deep sedation and mechanical ventilation will be sedated with an infusion of propofol and fentanyl guided by SEF95 obtained by SedLine® monitor to keep a SAS 1-2. The target of SEF95 will be 10-13 Hz to keep SAS 1-2.
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.
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.
Propofol and fentanyl will be infused to reach a score in the SAS of 1-2
Critically ill patients will be ventilated mechanically following the clinical indication.
Active Comparator: Control
Critical care patients with an indication of deep sedation and mechanical ventilation will be sedated with an infusion of propofol and fentanyl guided by SAS (1-2). SedLine® monitor will be also used in these patients but the screen will be covered.
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.
Propofol and fentanyl will be infused to reach a score in the SAS of 1-2
Critically ill patients will be ventilated mechanically following the clinical indication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma concentration of propofol
Time Frame: 48 hours
It will be measured using HPLC
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total dose of propofol
Time Frame: Each 2 hours for 48 hours
In mg
Each 2 hours for 48 hours
Total dose of fentanyl
Time Frame: Each 2 hours for 48 hours
In mcg
Each 2 hours for 48 hours
SAS (Sedation Agitation Scale)
Time Frame: Each 2 hours for 48 hours
The 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.
Each 2 hours for 48 hours
SEF95
Time Frame: Each 2 hours for 48 hours
Spectral Edge Frequency 95
Each 2 hours for 48 hours
Mean Arterial Pressure
Time Frame: Each 2 hours for 48 hours
In mmHg
Each 2 hours for 48 hours
Plasma triglyceride levels
Time Frame: 24 hours and 48 hours
Central laboratory
24 hours and 48 hours
Plasma lactate concentration
Time Frame: 24 hours and 48 hours
Central laboratory
24 hours and 48 hours
Duration of mechanical ventilation
Time Frame: Up to 30 days
Since the beginning of the protocol
Up to 30 days
Stay in intensive unit care
Time Frame: Up to 30 days
Since the beginning of the protocol
Up to 30 days
Wake up after stopping the infusion of propofol
Time Frame: Up to 48 hours
Up to 48 hours
Delirium
Time Frame: Up to 10 days
Evaluated with CAM-ICU twice a day during the stay in ICU
Up to 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Felipe Maldonado, MD, University of Chile
  • Principal Investigator: Antonello Penna, MD/PhD, University of Chile
  • Principal Investigator: Rodrigo Gutiérrez, MD, University of Chile
  • Principal Investigator: José Ignacio Egaña, MD/PhD, University of Chile
  • Principal Investigator: Eduardo Tobar, MD, University of Chile
  • Principal Investigator: Veronica Rojas, Nurse/MSc, University of Chile

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2019

Primary Completion (Actual)

April 1, 2021

Study Completion (Actual)

April 1, 2021

Study Registration Dates

First Submitted

July 15, 2019

First Submitted That Met QC Criteria

July 18, 2019

First Posted (Actual)

July 19, 2019

Study Record Updates

Last Update Posted (Actual)

November 4, 2022

Last Update Submitted That Met QC Criteria

November 2, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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