Spectral Edge Frequency From Spectral EEG Analysis to Guide Deep Sedation in the Critical Care Setting (Pilot)
Status:
Suspended
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
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.