Deep SedationSEFICUNCT04026451
Spectral Edge Frequency From Spectral EEG Analysis to Guide Deep Sedation in the Critical Care Setting (Pilot)
A study testing Sedation guided by SEF95 (10-13 Hz) from SedLine® monitor, Sedation guided by SAS scale (1-2) and Deep sedation with propofol andfentanyl in people with Deep Sedation and Mechanical Ventilation, run by University of Chile at 2 sites in Chile.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Deep Sedation, Mechanical Ventilation
- What is being tested?
- Sedation guided by SEF95 (10-13 Hz) from SedLine® monitor, Sedation guided by SAS scale (1-2) and Deep sedation with propofol andfentanyl
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesChile
- Study dates
- 11 Nov 2019to 1 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Older than 18 years
- Indication of deep sedation with propofol and fentanyl for more than 48 h
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Chile2 sites
Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile
Santiago, RM, 7690306
Hospital Clinico de la Universidad de Chile
Santiago, RM, 7690306
About this study
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
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.
Read the 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
- Being tested
- Sedation guided by SEF95 (10-13 Hz) from SedLine® monitor, Sedation guided by SAS scale (1-2), Deep sedation with propofol andfentanyl, Mechanical Ventilation
- Keywords
- Sedation, EEG, Mechanical Ventilation, Critical Care, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedation guided by SEF95 (10-13 Hz) from SedLine® monitorDevice
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)Behavioural
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.
Deep sedation with propofol andfentanylDrug
Propofol and fentanyl will be infused to reach a score in the SAS of 1-2
Mechanical VentilationProcedure or surgery
Critically ill patients will be ventilated mechanically following the clinical indication.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Sedation guided by SAS scale (1-2); Drug: Deep sedation with propofol andfentanyl; Procedure: Mechanical Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of propofol
It will be measured using HPLC
Measured: 48 hours
Secondary outcomes (11)
Total dose of propofol
In mg
Measured: Each 2 hours for 48 hours
Total dose of fentanyl
In mcg
Measured: Each 2 hours for 48 hours
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.
Measured: Each 2 hours for 48 hours
SEF95
Spectral Edge Frequency 95
Measured: Each 2 hours for 48 hours
Mean Arterial Pressure
In mmHg
Measured: Each 2 hours for 48 hours
Plasma triglyceride levels
Central laboratory
Measured: 24 hours and 48 hours
Plasma lactate concentration
Central laboratory
Measured: 24 hours and 48 hours
Duration of mechanical ventilation
Since the beginning of the protocol
Measured: Up to 30 days
Stay in intensive unit care
Since the beginning of the protocol
Measured: Up to 30 days
Wake up after stopping the infusion of propofol
Measured: Up to 48 hours
Delirium
Evaluated with CAM-ICU twice a day during the stay in ICU
Measured: Up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start11 Nov 2019
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Why it stopped: It was suspendend because the protocol and the aims were modified
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep SedationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonello Penna, University of Chile
- Investigators
- Antonello Penna, MD/PhD, Principal investigator, University of ChileRodrigo Gutiérrez, MD, Principal investigator, University of ChileFelipe Maldonado, MD, Principal investigator, University of ChileJosé Ignacio Egaña, MD/PhD, Principal investigator, University of ChileEduardo Tobar, MD, Principal investigator, University of ChileVerónica Rojas, Nurse/MSc, Principal investigator, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026451
- Sponsor's protocol ID
- 1009/18
- Acronym
- SEFICU
- Status last verified
- Nov 2022
- First submitted
- 15 Jul 2019
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04026451
- Acronym / sponsor ID
- SEFICU / 1009/18
- Conditions
- Deep Sedation, Mechanical Ventilation
- Keywords
- Sedation, EEG, Mechanical Ventilation, Critical Care, Propofol
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: It was suspendend because the protocol and the aims were modified
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 19 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | 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 VentilationCritical 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 | Active comparator | Behavioral: Sedation guided by SAS scale (1-2), Drug: Deep sedation with propofol andfentanyl, Procedure: Mechanical VentilationCritical 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Older than 18 years
- Indication of deep sedation with propofol and fentanyl for more than 48 h
Key exclusion criteria (6 listed)
- Brain damage
- Cognitive impairment
- Allergy to propofol or fentanyl
- Limitation of therapeutic effort
- Liver chronic disease Child C
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sedation guided by SEF95 (10-13 Hz) from SedLine® monitorDosage 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. | Device | Intervention |
| 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. | Behavioural | Control, Intervention |
| Deep sedation with propofol andfentanylPropofol and fentanyl will be infused to reach a score in the SAS of 1-2 | Drug | Control, Intervention |
| Mechanical VentilationCritically ill patients will be ventilated mechanically following the clinical indication. | Procedure or surgery | Control, Intervention |
Primary outcome
Plasma concentration of propofol
Time frame: 48 hours
It will be measured using HPLC
11 secondary outcomes
Total dose of propofol
Time frame: Each 2 hours for 48 hours
Total dose of fentanyl
Time frame: Each 2 hours for 48 hours
SAS (Sedation Agitation Scale)
Time frame: Each 2 hours for 48 hours
SEF95
Time frame: Each 2 hours for 48 hours
Mean Arterial Pressure
Time frame: Each 2 hours for 48 hours
Plasma triglyceride levels
Time frame: 24 hours and 48 hours
Plasma lactate concentration
Time frame: 24 hours and 48 hours
Duration of mechanical ventilation
Time frame: Up to 30 days
Stay in intensive unit care
Time frame: Up to 30 days
Wake up after stopping the infusion of propofol
Time frame: Up to 48 hours
Delirium
Time frame: Up to 10 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonello Penna, MD/PhD principal investigator
University of Chile
Rodrigo Gutiérrez, MD principal investigator
University of Chile
Felipe Maldonado, MD principal investigator
University of Chile
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sedation guided by SEF95 (10-13 Hz) from SedLine® monitor, Sedation guided by SAS scale (1-2) and Deep sedation with propofol andfentanyl in people with Deep Sedation and Mechanical Ventilation, run by University of Chile at 2 sites in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentration of propofol (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.