Sedation ComplicationNCT06337877
Assessment of Sedation Depth Using Processed EEG in ICU Patients With ARDS Receiving Neuromuscular Blockade: A Prospective Observational Study"
An observational study of Sedation Complication and Acute Respiratory Distress Syndrome Due to COVID-19, run by Tepecik Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
"In intensive care units, therapeutic paralysis has been a routine treatment method for many years in a select group of patients. Sufficient and appropriate sedation in patients undergoing therapeutic paralysis is crucial to prevent awareness and reduce the risk of excessive sedation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sedation Complication, Acute Respiratory Distress Syndrome Due to COVID-19, Anesthesia Awareness
- What is being tested?
- Depth of sedation monitoring
- Type of treatment
- Surgery or procedure
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 24 Apr 2024
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Intensive care unit patients who has ARDS
Who may be able to join
- "Patients aged 18 years and older who have received continuous neuromuscular blocking agents for at least 24 hours."
Who cannot join
- Patients under 18 years of age,
- pregnant individuals
- trauma patients,
- intracerebral pathology
- major bleeding
- central nervous system diseases,
- pre-existing poor neurological condition before admission to the intensive care unit,
- inability to document continuous neuromuscular blocking agent infusion for at least 24 hours."
Trial locations and contacts
1 site in 1 country.
About this study
"In intensive care units, therapeutic paralysis has been a routine treatment method for many years in a select group of patients. Sufficient and appropriate sedation in patients undergoing therapeutic paralysis is crucial to prevent awareness and reduce the risk of excessive sedation. Both inadequate and excessive sedation levels can be highly detrimental to the patient. Clinical assessment may not always provide accurate information regarding sedation depth. Recently, the frequency and workload of therapeutic paralysis treatment in intensive care units have increased due to COVID-19 pneumonia. Therefore, the investigators believe that inadequate sedation may be common in these patients. Processed electroencephalogram parameters such as bispectral index or patient state index (PSI), routinely used in operating rooms and intensive care units, are commonly used to indicate sedation depth. In this study, the investigators aimed to determine sedation levels in patients during paralysis, assess the prevalence of inadequate or excessive sedation, and observe the doses of sedatives and analgesics used."
- Conditions
- Sedation Complication, Acute Respiratory Distress Syndrome Due to COVID-19, Anesthesia Awareness
- Being tested
- Depth of sedation monitoring
- Medical subject headings
- Intraoperative Awareness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depth of sedation monitoringProcedure or surgery
In the study, group rates of patient state index (PSI) [(below 25); (25-50); (51-75); (above 75)] will be determined within a 24-hour timeframe in patients undergoing therapeutic paralysis. The concordance between PSI rates* determined at baseline (time zero) and Richmond Agitation-Sedation Scale (RASS) [(between -4 and -5); (between -3 and -2); (equal to or greater than -1)] rates will be assessed. Suppression rate (SR) and electromyography (EMG) values will be obtained from patients, and significant differences among PSI groups [(below 25); (25-50); (51-75); (above 75)] in terms of these data will be examined. Additionally, changes in Propofol (mg/hour), Midazolam (mg/hour), Fentanyl (mg/hour), and Rocuronium (mg/hour) values will be analyzed for each time interval.
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the sedation levels of patients during paralysis
"In the study, for patients undergoing therapeutic paralysis, routinely applied non-invasive patient state index (0-100) values will be recorded. These recorded values will be blindedly recorded from the clinician, who will not be alerted or intervene based on the values."
Measured: For patients undergoing therapeutic paralysis, over a 24-hour period,"
The prevalence of inadequate or excessive sedation,
"In the study, for patients undergoing therapeutic paralysis, routinely applied non-invasive patient state index (0-100) values will be recorded. These recorded values will be blindedly recorded from the clinician, who will not be alerted or intervene based on the values."
Measured: For patients undergoing therapeutic paralysis, over a 24-hour period,"
Secondary outcomes (1)
Evaluation of Concordance Between Richmond Agitation-Sedation Scale (RASS),
Evaluation of Concordance Between Richmond Agitation-Sedation Scale [(+4)- (-5)], a scale used in clinical assessment.
Measured: The assessment process conducted immediately before the application of paralysis."
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start1 Oct 2023
- Primary completion17 Apr 2024
- Study completion24 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedation ComplicationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tepecik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aykut Saritas, Tepecik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337877
- Sponsor's protocol ID
- pEEG ARDS
- Status last verified
- May 2025
- First submitted
- 17 Mar 2024
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Sedation Depth Using Processed EEG in ICU Patients With ARDS Receiving Neuromuscular Blockade: A Prospective Observational Study"
- ClinicalTrials.gov ID
- NCT06337877
- Acronym / sponsor ID
- pEEG ARDS
- Conditions
- Sedation Complication, Acute Respiratory Distress Syndrome Due to COVID-19, Anesthesia Awareness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Tepecik Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 17 Apr 2024 (actual)
- Study completion
- 24 Apr 2024 (actual)
- First posted
- 29 Mar 2024 (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.
"In intensive care units, therapeutic paralysis has been a routine treatment method for many years in a select group of patients. Sufficient and appropriate sedation in patients undergoing therapeutic paralysis is crucial to prevent awareness and reduce the risk of excessive sedation. Both inadequate and excessive sedation levels can be highly detrimental to the patient. Clinical assessment may not always provide accurate information regarding sedation depth. Recently, the frequency and workload of therapeutic paralysis treatment in intensive care units have increased due to COVID-19 pneumonia. Therefore, the investigators believe that inadequate sedation may be common in these patients. Processed electroencephalogram parameters such as bispectral index or patient state index (PSI), routinely used in operating rooms and intensive care units, are commonly used to indicate sedation depth. In this study, the investigators aimed to determine sedation levels in patients during paralysis, assess the prevalence of inadequate or excessive sedation, and observe the doses of sedatives and analgesics used."
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Intensive care unit patients who has ARDS
Key inclusion criteria (1 listed)
- "Patients aged 18 years and older who have received continuous neuromuscular blocking agents for at least 24 hours."
Key exclusion criteria (8 listed)
- Patients under 18 years of age,
- pregnant individuals
- trauma patients,
- intracerebral pathology
- major bleeding
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 |
|---|---|---|
| Depth of sedation monitoringIn the study, group rates of patient state index (PSI) [(below 25); (25-50); (51-75); (above 75)] will be determined within a 24-hour timeframe in patients undergoing therapeutic paralysis. The concordance between PSI rates* determined at baseline (time zero) and Richmond Agitation-Sedation Scale (RASS) [(between -4 and -5); (between -3 and -2); (equal to or greater than -1)] rates will be assessed. Suppression rate (SR) and electromyography (EMG) values will be obtained from patients, and significant differences among PSI groups [(below 25); (25-50); (51-75); (above 75)] in terms of these data will be examined. Additionally, changes in Propofol (mg/hour), Midazolam (mg/hour), Fentanyl (mg/hour), and Rocuronium (mg/hour) values will be analyzed for each time interval. | Procedure or surgery | – |
Primary outcome
To determine the sedation levels of patients during paralysis
Time frame: For patients undergoing therapeutic paralysis, over a 24-hour period,"
"In the study, for patients undergoing therapeutic paralysis, routinely applied non-invasive patient state index (0-100) values will be recorded. These recorded values will be blindedly recorded from the clinician, who will not be alerted or intervene based on the values."
The prevalence of inadequate or excessive sedation,
Time frame: For patients undergoing therapeutic paralysis, over a 24-hour period,"
"In the study, for patients undergoing therapeutic paralysis, routinely applied non-invasive patient state index (0-100) values will be recorded. These recorded values will be blindedly recorded from the clinician, who will not be alerted or intervene based on the values."
1 secondary outcome
Evaluation of Concordance Between Richmond Agitation-Sedation Scale (RASS),
Time frame: The assessment process conducted immediately before the application of paralysis."
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sedation Complication and Acute Respiratory Distress Syndrome Due to COVID-19, run by Tepecik Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 8 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: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the sedation levels of patients during paralysis (time frame: For patients undergoing therapeutic paralysis, over a 24-hour period,"). The study lists 2 primary outcomes in all. 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 11 Jun 2025.