Assessment of Sedation Depth in ARDS Patients Undergoing Therapeutic Paralysis

Sedation Complication Clinical Trial

Official title:

"Assessment of Sedation Depth in ARDS Patients Undergoing Therapeutic Paralysis: A Processed EEG Monitoring Approach in Intensive Care Unit"

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06337877
• Other study ID #: pEEG ARDS
• Status: Active, not recruiting
• Start date: October 1, 2023
• Est. completion date: April 24, 2024

Study information

• Verified date: March 2024
• Source: Tepecik Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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."

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 52
• Est. completion date: April 24, 2024
• Est. primary completion date: April 17, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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."

Related Conditions & MeSH terms

• Acute Lung Injury
• Anesthesia Awareness
• Intraoperative Awareness
• Paralysis
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Sedation Complication

Intervention

Procedure:
• Depth of sedation monitoring
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.

Locations

Country	Name	City	State
Turkey	Aykut Saritas	I?zmi?r

Sponsors (1)

Lead Sponsor	Collaborator
Tepecik Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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,"
Primary	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	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."