Electroencephalography and Sleep Quality With Lormetazepam in the Intensive Care Unit
NCT Number: NCT06473415
Acronym: CLIO-ICU
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Critical Illness|Delirium|Sleep Disorders, Circadian Rhythm
Interventions: DIAGNOSTIC_TEST: Electroencephalography
Sponsor: Charite University, Berlin, Germany
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-12-01
Completion Date: 2024-12-31
Locations: Charité - Universitätsmedizin Berlin, Berlin-Mitte, Berlin, 10117, Germany

Summary:
The goal of this clinical trial is to test the effect of continuous lormetazepam infusion on EEG patterns in critically ill patients who are given continuous infusion of lormetazepam in an intensive care unit setting. The main questions it aims to answer are:

• How does the continuous infusion of lormetazepam affect EEG readings in terms of specific patterns related to sleep quality and sedation depth?

Participants will be asked to:

* Receive continuous infusion of lormetazepam, administered as per the guidelines and judgment of the on-duty ward physician.
* Undergo up to three EEG measurements over a period of 24 hours each using the X8 Sleep Profiler RTA device. These measurements will monitor brain activity and other related signals in order to assess the sedation depth and sleep quality.
* These EEG readings will be performed after at least two hours of initiation of continuous lormetazepam infusion, potentially at different stages of their ICU stay.

There is no direct comparison group in this study. However, after initial data from the first 15 patients is collected, an interim analysis will be performed. This will help researchers understand the ability to measure sleep quality and defined EEG parameters in this setup, and if necessary, adapt the study design or measurement procedures for better outcomes.

Primary Outcome Measures: REM portion (%) during nocturnal sleep, Main Hypothesis: Intensive care patients who receive a continuous Lormetazepam infusion exhibit an electroencephalographically detectable REM portion of at least 20% during the nocturnal sleeping period bewetween 22:00 to 06:00., through study completion per patient, an average of 3 days
Secondary Outcome Measures: Total sleep time attributed to stages N2, N3 or rapid eye movement (REM) sleep during the noctural period i.e., between the hours of 22:00 and 06:00, Total high qualitiy sleep time during nocturnal period, (sum REM,N2,N3; minutes), through study completion per patient, an average of 3 days|Total minutes of all stages of sleep (including N1, AN3, NREM hypertonia) during the awake period i.e., between the hours of 06:00 and 22:00., Total sleep time during awake period, (minutes), through study completion per patient, an average of 3 days|Total and % time atypical N3 sleep (AN3) i.e. polymorphic delta or or sepsis associated encephalopathy, Total sleep time in atypical N3 (minutes; %), through study completion per patient, an average of 3 days|Gamma oscillations, Hz), through study completion per patient, an average of 3 days|Theta-Gamma Coupling, (TGC, Modulation Index), through study completion per patient, an average of 3 days|Polymorphic Delta/Theta Ratio, (DTR, %), through study completion per patient, an average of 3 days|Slow Wave Sleep (SWS) Characteristics, This outcome measure will aggregate the characteristics of Slow Wave Sleep (SWS) by reporting the total duration (in minutes) and the average frequency (in Hz) during each measurement period. The aggregated value will combine these measurements to provide a comprehensive assessment of SWS., through study completion per patient, an average of 3 days|Pathological N3-Slow Wave Sleep Characteristics, This outcome measure will aggregate the characteristics of Pathological N3-Slow Wave Sleep by reporting the total duration (in minutes) and the average frequency (in Hz) during each measurement period. The aggregated value will combine these measurements to provide a comprehensive assessment of N3-Slow Wave Sleep., through study completion per patient, an average of 3 days|Sleep Spindle Characteristics, This outcome measure will aggregate the characteristics of sleep spindles by reporting the total occurrence (number per minute/hour), average frequency (in Hz), and total duration (in minutes) during each measurement period. The aggregated value will combine these measurements to provide a comprehensive assessment of sleep spindles., through study completion per patient, an average of 3 days|Pseudo Spindle Characteristics supression and/or medications, This outcome measure will aggregate the characteristics of pseudo spindles by reporting the total duration (in minutes attributed to burst suppression and/or medications), average frequency (in Hz), and total occurrence (number per minute/hour) during each measurement period. The aggregated value will combine these measurements to provide a comprehensive assessment of pseudo spindles., through study completion per patient, an average of 3 days|K-Complex Characteristics, This outcome measure will aggregate the characteristics of K-complexes by reporting the total occurrence (number per minute/hour) and average frequency (in Hz) during each measurement period. The aggregated value will combine these measurements to provide a comprehensive assessment of K-complexes., through study completion per patient, an average of 3 days|Burst-Suppression, (Supression Index,%), through study completion per patient, an average of 3 days|Total sleep time, (minutes), through study completion per patient, an average of 3 days|Sleep latency, (SOL, minutes), through study completion per patient, an average of 3 days|Nocturnal sleep efficiency (%), (Total sleep duration/8 hours) x 100, through study completion per patient, an average of 3 days|Eye movements during sleep, (number), through study completion per patient, an average of 3 days|REM latency, (minutes), through study completion per patient, an average of 3 days|REM-Sleep-Pressure-Index, (RSPI, %), through study completion per patient, an average of 3 days|Delirium incidence in intensive care unit measured with the Confusion Assessment Method, CAM-ICU, through study completion per patient, an average of 3 days|Delirium severity in intensive care unit measured with the Intensive Care Delirium Screening Checklist, (ICDSC), through study completion per patient, an average of 3 days|Sedation depth: Richmond Agitation Sedation Scale, The Richmond Agitation Sedation Scale (RASS) ranges from -5 to +4, with lower scores indicating deeper sedation and higher scores indicating greater agitation. The scale includes +4 (combative), +3 (very agitated), +2 (agitated), +1 (restless), 0 (alert and calm), -1 (drowsy), -2 (light sedation), -3 (moderate sedation), -4 (deep sedation), and -5 (unarousable). Higher scores indicate worse outcomes in terms of agitation(RASS), through study completion per patient, an average of 3 days|Analgesia level: Numeric Rating Scale Visualized (NRS-V) or Faces Pain Scale Revised (FAS-R) Behavioural Pain Scale (BPS) or Behavioural Pain Scale for non-intubated patients (BPS-NI), The analgesia level will be assessed using the Numeric Rating Scale Visualized (NRS-V), Faces Pain Scale Revised (FAS-R), Behavioural Pain Scale (BPS), or Behavioural Pain Scale for non-intubated patients (BPS-NI). The NRS-V ranges from 0 (no pain) to 10 (worst pain imaginable). The FAS-R uses facial expressions to represent pain levels from 0 (no pain) to 10 (worst pain imaginable). The BPS scores range from 3 (no pain) to 12 (severe pain) based on facial expression, upper limb movements, and compliance with ventilation. The BPS-NI scores range from 3 (no pain) to 12 (severe pain) based on facial expression, upper limb movements, and vocalization. Higher scores indicate worse pain outcomes., through study completion per patient, an average of 3 days|Total amount of intravenously administered opioids per ICU treatment day, type, cumulative dose, through study completion per patient, an average of 3 days|Total amount of administered neuroleptics per ICU treatment day, type, cumulative dose, through study completion per patient, an average of 3 days|Duration of invasive and non-invasive ventilation, intubated, nasal highflow, NIV-mask, through study completion per patient, an average of 3 days|Intensive care duration at the center, days, through study completion, an average of 1 year|Hospital treatment duration at the center, days, through study completion, an average of 1 year|Sepsis/Septic Shock, Sepsis/Septic Shock, through study completion per patient, an average of 3 days|Sequential Organ Failure Assessment, The Sequential Organ Failure Assessment (SOFA) Score assesses organ function and predicts outcomes in critically ill patients. The score ranges from 0 to 24, with higher scores indicating greater organ dysfunction. It evaluates six organ systems: respiratory, cardiovascular, hepatic, coagulation, renal, and neurological. Each system is scored from 0 (normal function) to 4 (high degree of dysfunction). Higher SOFA scores are associated with worse patient outcomes (SOFA)., through study completion per patient, an average of 3 days|Simplified Acute Physiology Score, The Simplified Acute Physiology Score II (SAPS II) is used to assess the severity of disease for patients admitted to intensive care units. The score ranges from 0 to 163, with higher scores indicating a higher risk of mortality. SAPS II includes 17 variables: 12 physiological variables, age, type of admission (scheduled surgical, unscheduled surgical, medical), and three underlying disease variables (AIDS, hematologic malignancy, metastatic cancer). Higher SAPS II scores correspond to worse patient outcomes (SAPSII)., through study completion per patient, an average of 3 days|Therapeutic Intervention Scoring System, The Therapeutic Intervention Scoring System (TISS) measures the intensity of medical and nursing care required by ICU patients. The score ranges from 0 to 78, with higher scores indicating more intensive care. TISS evaluates various therapeutic interventions, including cardiovascular, renal, respiratory, and neurological support, as well as monitoring, medication, and hygiene procedures. Higher TISS scores reflect a greater need for medical and nursing interventions (TISS)., through study completion per patient, an average of 3 days|Acute Physiological And Chronic Health Evaluation, The Acute Physiology and Chronic Health Evaluation II (APACHE II) score is used to measure the severity of disease in ICU patients. The score ranges from 0 to 71, with higher scores indicating more severe disease and higher risk of mortality. APACHE II includes the evaluation of 12 physiological variables, age, and chronic health status. Higher APACHE II scores are associated with worse patient outcomes (APACHE II)., through study completion per patient, an average of 3 days|Age, (years), through study completion per patient, an average of 3 days|Gender, (m/f/d), through study completion per patient, an average of 3 days|Fever, yes/no, days), through study completion per patient, an average of 3 days|Respiratory insufficiency/Asthma (yes/no), (yes/no), through study completion per patient, an average of 3 days|Cardiac arrest/Cardiac decompensation, (yes/no), through study completion per patient, an average of 3 days|Pneumonia, (yes/no), through study completion per patient, an average of 3 days|Urinary tract infection, (yes/no), through study completion per patient, an average of 3 days|Exacerbated COPD, (yes/no), through study completion per patient, an average of 3 days|Hypervolemia, (yes/no), through study completion per patient, an average of 3 days|Meningitis, (yes/no), through study completion per patient, an average of 3 days|Pancreatitis, (yes/no), through study completion per patient, an average of 3 days|Cirrhosis, (yes/no), through study completion per patient, an average of 3 days|Kidney insufficiency, (yes/no), through study completion per patient, an average of 3 days|Thrombocytopenia, (yes/no), through study completion per patient, an average of 3 days|Leukocytosis, (yes/no), through study completion per patient, an average of 3 days|Leukopenia, (yes/no), through study completion per patient, an average of 3 days|Hypotonia, (yes/no), through study completion per patient, an average of 3 days|Death, (yes/no), through study completion per patient, an average of 3 days