Assessment of Sedation Depth in ARDS Patients Undergoing Therapeutic Paralysis

Active, not recruiting

• Conditions: Anesthesia Awareness; Sedation Complication; Acute Respiratory Distress Syndrome Due to COVID-19

• Registration Number: NCT06337877
• Lead Sponsor: Tepecik Training and Research Hospital

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."

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-17
• Study First Submitted QC: 2024-03-22
• Last Update Submitted: 2024-03-22
• Study First Posted: 2024-03-29
• Last Update Posted: 2024-03-29
• Primary Completion: 2024-04-17
• Study Completion: 2024-04-24

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the sedation levels of patients during paralysis	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,	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."

Secondary Outcome Measures

Name	Time	Method
Evaluation of Concordance Between Richmond Agitation-Sedation Scale (RASS),	The assessment process conducted immediately before the application of paralysis."	Evaluation of Concordance Between Richmond Agitation-Sedation Scale \[(+4)- (-5)\], a scale used in clinical assessment.

Trial Locations

Locations (1)

Aykut Saritaş; 🇹🇷 İ̇zmi̇r, Turkey