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

Study Overview

• Status: Completed
• Conditions: Sedation Complication; Anesthesia Awareness; Acute Respiratory Distress Syndrome Due to COVID-19
• Intervention / Treatment: Procedure: Depth of sedation monitoring

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• Turkey
  • İzmir
    • İ̇zmi̇r, İzmir, Turkey, 35640
      • Aykut Saritaş

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Intensive care unit patients who has ARDS

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients under 18 years of age,
2. pregnant individuals
3. trauma patients,
4. intracerebral pathology
5. major bleeding
6. central nervous system diseases,
7. pre-existing poor neurological condition before admission to the intensive care unit,
8. inability to document continuous neuromuscular blocking agent infusion for at least 24 hours."

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The assessment process conducted immediately before the application of paralysis."

Collaborators and Investigators

• Sponsor: Tepecik Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): April 17, 2024
• Study Completion (Actual): April 24, 2024

Study Registration Dates

• First Submitted: March 17, 2024
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Actual): June 11, 2025
• Last Update Submitted That Met QC Criteria: June 7, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury; Intraoperative Complications; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Intraoperative Awareness
• Other Study ID Numbers: pEEG ARDS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No