Mechanical Ventilation Clinical Trial
— SEFICUOfficial 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
NCT number | NCT04026451 |
Other study ID # | 1009/18 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | November 11, 2019 |
Est. completion date | April 1, 2021 |
Verified date | November 2022 |
Source | University of Chile |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
University of Chile |
Chile,
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 |
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