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

Mechanical Ventilation Clinical Trial

— SEFICU  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04026451
• Other study ID #: 1009/18
• Status: Withdrawn
• Phase: N/A
• Start date: November 11, 2019
• Est. completion date: April 1, 2021

Study information

• Verified date: November 2022
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Deep Sedation
• Mechanical Ventilation

Intervention

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.

Locations

Country	Name	City	State
Chile	Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile	Santiago	RM
Chile	Hospital Clinico de la Universidad de Chile	Santiago	RM

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

Outcome

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