Assessment of Sedation Depth Using Processed EEG in ICU Patients With ARDS Receiving Neuromuscular Blockade: A Prospective Observational Study"

NCT06337877 | Completed

• 1 other identifier: pEEG ARDS
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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."

  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."

  For patients undergoing therapeutic paralysis, over a 24-hour period,"

Secondary Outcomes (1)

• Evaluation of Concordance Between Richmond Agitation-Sedation Scale (RASS),

  The assessment process conducted immediately before the application of paralysis."

Interventions

Depth of sedation monitoring PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Intensive care unit patients who has ARDS

You may qualify if:

• "Patients aged 18 years and older who have received continuous neuromuscular blocking agents for at least 24 hours."

You may not qualify if:

• 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."

Sponsors & Collaborators

• Tepecik Training and Research Hospital: lead

Study Sites (1)

Aykut Saritaş

Izmir, İzmir, 35640, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intraoperative Awareness

Condition Hierarchy (Ancestors)

Intraoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associated professor

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: March 29, 2024
• Study Start: October 1, 2023
• Primary Completion: April 17, 2024
• Study Completion: April 24, 2024
• Last Updated: June 11, 2025

Record last verified: 2025-05

Locations

TU (1)