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

NCT04026451 | Withdrawn DMC FDA Device

• 1 other identifier: 1009/18
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Deep Sedation; Mechanical Ventilation

Keywords

Sedation; EEG; Mechanical Ventilation; Critical Care; Propofol

Outcome Measures

Primary Outcomes (1)

• Plasma concentration of propofol

  It will be measured using HPLC

  48 hours

Secondary Outcomes (11)

• Total dose of propofol

  Each 2 hours for 48 hours

• Total dose of fentanyl

  Each 2 hours for 48 hours

• SAS (Sedation Agitation Scale)

  Each 2 hours for 48 hours

• SEF95

  Each 2 hours for 48 hours

• Mean Arterial Pressure

  Each 2 hours for 48 hours

Study Arms (2)

Intervention

EXPERIMENTAL

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.

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

Control

ACTIVE COMPARATOR

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.

Behavioral: Sedation guided by SAS scale (1-2); Drug: Deep sedation with propofol andfentanyl; Procedure: Mechanical Ventilation

Interventions

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

Intervention

Sedation guided by SAS scale (1-2) 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; Intervention

Deep sedation with propofol andfentanyl DRUG

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

Control; Intervention

Mechanical Ventilation PROCEDURE

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

Control; Intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Older than 18 years
• Indication of deep sedation with propofol and fentanyl for more than 48 h

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chile: lead

Study Sites (2)

Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile

Santiago, RM, 7690306, Chile

Location

Hospital Clinico de la Universidad de Chile

Santiago, RM, 7690306, Chile

Location

MeSH Terms

Interventions

Deep Sedation; Respiration, Artificial

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Study Officials

• Antonello Penna, MD/PhD

  University of Chile

  PRINCIPAL INVESTIGATOR

• Rodrigo Gutiérrez, MD

  University of Chile

  PRINCIPAL INVESTIGATOR

• Felipe Maldonado, MD

  University of Chile

  PRINCIPAL INVESTIGATOR

• José Ignacio Egaña, MD/PhD

  University of Chile

  PRINCIPAL INVESTIGATOR

• Eduardo Tobar, MD

  University of Chile

  PRINCIPAL INVESTIGATOR

• Verónica Rojas, Nurse/MSc

  University of Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist, MD, PhD

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 19, 2019
• Study Start: November 11, 2019
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: November 4, 2022

Record last verified: 2022-11

Locations

CL (2)