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

NCT ID: NCT04026451

Last Updated: 2022-11-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-11
• Study Completion Date: 2021-04-01

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.

Conditions

Deep Sedation; Mechanical Ventilation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Deep sedation with propofol andfentanyl

Intervention Type: DRUG

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

Mechanical Ventilation

Intervention Type: PROCEDURE

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

Sedation guided by SEF95 (10-13 Hz) from SedLine® monitor

Intervention Type: DEVICE

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.

Sedation guided by SAS scale (1-2)

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Deep sedation with propofol andfentanyl

Intervention Type: DRUG

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

Mechanical Ventilation

Intervention Type: PROCEDURE

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

Sedation guided by SAS scale (1-2)

Intervention Type: BEHAVIORAL

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.

Interventions

Deep sedation with propofol andfentanyl

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

Intervention Type: DRUG

Mechanical Ventilation

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

Intervention Type: PROCEDURE

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.

Intervention Type: DEVICE

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chile

OTHER

Sponsor Role: lead

Responsible Party

Antonello Penna

Anesthesiologist, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonello Penna, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

University of Chile

Rodrigo Gutiérrez, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chile

Felipe Maldonado, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chile

José Ignacio Egaña, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

University of Chile

Eduardo Tobar, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chile

Verónica Rojas, Nurse/MSc

Role: PRINCIPAL_INVESTIGATOR

University of Chile

Locations

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, Chile

Countries

Chile

Other Identifiers

1009/18

Identifier Type: -

Identifier Source: org_study_id