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

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.

Conditions

• Deep Sedation
• Mechanical Ventilation

Interventions

DEVICE

Sedation 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.

BEHAVIORAL

Sedation 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.

DRUG

Deep sedation with propofol andfentanyl

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

PROCEDURE

Mechanical Ventilation

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

Sponsors & Collaborators

• University of Chile

  lead OTHER

Principal Investigators

• Antonello Penna, MD/PhD · University of Chile

• Rodrigo Gutiérrez, MD · University of Chile

• Felipe Maldonado, MD · University of Chile

• José Ignacio Egaña, MD/PhD · University of Chile

• Eduardo Tobar, MD · University of Chile

• Verónica Rojas, Nurse/MSc · University of Chile

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-11-11

Primary Completion

2021-04-01

Completion

2021-04-01

FDA Device

Yes

Countries

• Chile

Study Locations