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

Not Applicable

Withdrawn

• Conditions: Deep Sedation; Mechanical Ventilation
• Interventions: Device: Sedation guided by SEF95 (10-13 Hz) from SedLine® monitor; Behavioral: Sedation guided by SAS scale (1-2); Procedure: Mechanical Ventilation; Drug: Deep sedation with propofol andfentanyl

• Registration Number: NCT04026451
• Lead Sponsor: University of Chile

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.

Study Timeline

• Study First Submitted: 2019-07-15
• Study First Submitted QC: 2019-07-18
• Study First Posted: 2019-07-19
• Study Start: 2019-11-11
• Primary Completion: 2021-04-01
• Study Completion: 2021-04-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Mechanical Ventilation	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.
Intervention	Sedation guided by SAS scale (1-2)	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.
Intervention	Deep sedation with propofol andfentanyl	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.
Control	Sedation guided by SAS scale (1-2)	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.
Intervention	Mechanical Ventilation	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.
Intervention	Sedation guided by SEF95 (10-13 Hz) from SedLine® monitor	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.
Control	Deep sedation with propofol andfentanyl	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.

Primary Outcome Measures

Name	Time	Method
Plasma concentration of propofol	48 hours	It will be measured using HPLC

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Hospital Clinico de la Universidad de Chile; 🇨🇱 Santiago, RM, Chile

Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile; 🇨🇱 Santiago, RM, Chile