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Neurologic DysfunctionNCT07441434

DuraEEG - Duration of EEG and Treatment Outcomes in Critical Care

An observational study of Neurologic Dysfunction, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this retrospective, observational, single-center study is to evaluate how electroencephalography (EEG) monitoring duration affects diagnosis and treatment in adult critical care patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neurologic Dysfunction
How many people
800 participants
Where
1 siteSwitzerland
Study dates
1 Jan 2014to 28 Feb 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population will include all consecutive adult patients (i.e., ≥18 years of age) who were treated at the University Hospital Basel and/or were selected for a close monitoring on a monitoring Unit for EEG or continuous EEG between 2014 and until the end of 02/2025.

Who may be able to join

  • Adult patients (i.e., patients ≥18 years of age)
  • Received an EEG/continuous EEG
  • Treated at the University Hospital of Basel on a suitable monitoring unit from 01.01.2014 - 28.02.2025.

Who cannot join

  • Patients younger than 18 years
  • Patients who did not receive suitable EEG monitoring
  • Patients with documented refusal of the general consent

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • University Hospital Basel, Clinic for Intensive Care Medicine

    Basel, Canton of Basel-City, 4031

Other trials in Switzerland

About this study

The aim of this retrospective, observational, single-center study is to evaluate how electroencephalography (EEG) monitoring duration affects diagnosis and treatment in adult critical care patients.

Read the detailed description

Electroencephalography (EEG) is a diagnostic tool that records the brain's real-time electrical activity, helping detect or rule out causes of altered mental or neurological status, including life-threatening emergencies such as status epilepticus or encephalopathies. EEG can be performed as short "Spot-EEG" sessions or continuously over several days using continuous video EEG monitoring (CVEM). Prolonged EEG recordings can increase the detection of epileptic seizures or nonconvulsive status epilepticus, although previous studies have not shown a clear effect on patient outcomes. EEG findings guide treatment decisions, including starting, adjusting, or stopping therapies, and inform investigations and interventions in conditions such as encephalopathy or after cardiac arrest.

This retrospective, observational, single-center cohort study aims to identify the EEG duration that balances the benefits of detecting therapy-relevant events with the risks, resource requirements, and potential complications of prolonged monitoring.

The results of this study may help improve individualized patient care, optimize EEG use in intensive care, and guide treatment and monitoring strategies to achieve better outcomes for critically ill patients.

Keywords
Electroencephalography, Intensive Care Unit
Medical subject headings
Neurologic Manifestations

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient demographics

    Demographic information (e.g. age, sex) is collected.

    Measured: 2014 - 02/2025

  2. Acute prehospital management data

    Data from acute prehospital management, as documented in emergency medical services (EMS) treatment protocols, is collected. The collected data elements are aggregated to describe the overall EMS response.

    Measured: 2014 - 02/2025

  3. Duration of intensive care unit stay

    The length of intensive care unit (ICU) stay is recorded.

    Measured: 2014 - 02/2025

  4. Duration of hospital stay

    The length of the total hospital stay is recorded.

    Measured: 2014 - 02/2025

  5. Discharge destination

    The destination at discharge is recorded.

    Measured: 2014 - 02/2025

  6. Neurological deficits

    The date(s) of onset and clinical course of neurological deficits, aggregated with additional clinical features are collected to capture the overall clinical presentation.

    Measured: 2014 - 02/2025

  7. Number of Nonconvulsive Status Epilepticus in ectroencephalogram

    Electroencephalograms (EEGs) are collected to assess neurological activity and monitor for abnormalities that may affect treatment.

    Measured: 2014 - 02/2025

  8. Medical history

    Patients' medical history, especially neurological and infectious disease history, is collected to provide a comprehensive overview of relevant clinical background.

    Measured: 2014 - 02/2025

  9. Disease etiology

    The underlying causes of relevant diseases, particularly neurological and infectious conditions, are collected provide a comprehensive overview of relevant clinical background.

    Measured: 2014 - 02/2025

  10. Previous episodes of altered neurologic function

    Information on previous episodes of altered neurological function, including their number and duration, is collected to provide a comprehensive measure of past disease burden.

    Measured: 2014 - 02/2025

  11. Imaging features

    Neuroimaging features and other imaging features obtained during diagnostic work-up are aggregated to provide a comprehensive assessment of structural and functional abnormalities.

    Measured: 2014 - 02/2025

  12. Comprehensive assessment of the neurological status based on Richmond Agitation-Sedation Scale (RASS)

    Neurological status during ICU stay is assessed using available data in the patient register from validated neurological assessments. These may include the Richmond Agitation-Sedation Scale (RASS), Sedation-Agitation Scale (SAS), Glasgow Coma Scale (GCS), or Intensive Care Delirium Screening Checklist (ICDSC). If multiple scores are available, they will be aggregated to provide a comprehensive assessment of neurological status. This outcome will be reported as a descriptive summary, synthesizing findings across tools, rather than as a single quantitative score. Richmond Agitation-Sedation Scale (RASS) is a 10-point validated tool (ranging from +4 to -5) used in intensive care to quickly assess a patient's level of sedation or agitation. A RASS score of 0 indicates an alert and calm patient, while positive scores represent agitation and negative scores indicate sedation.

    Measured: 2014 - 02/2025

  13. Comprehensive assessment of critical illness severity based on standardized scoring including the Acute Physiology and Chronic Health Evaluation II (APACHE II)systems

    Disease severity during ICU stay is assessed using standardized scoring systems, including the Acute Physiology and Chronic Health Evaluation II (APACHE II), Simplified Acute Physiology Score II (SAPS II), and Sequential Organ Failure Assessment (SOFA), depending on data availability in the patient register. The specific scoring system applied, as well as the scale and interpretation of the score, varies based on routine clinical practice and available documentation. Where multiple severity scores are available, they will be synthesized to provide a descriptive summary of overall illness severity rather than a single quantitative score. APACHE II uses 12 routine physiologic measurements, age, and chronic health status-collected within 24 hours of ICU admission-to calculate a score (0 to 71) predicting mortality risk. Higher scores correspond to higher disease severity.

    Measured: 2014 - 02/2025

  14. Charlson Comorbidity Index

    The Charlson Comorbidity Index (CCI) is calculated based on pre-existing comorbidities and additional diagnoses. The CCI predicts the ten-year mortality for a patient who may have a range of comorbid conditions. It assigns weighted scores (from 0 to maximal 6) to 17 comorbid conditions (e.g., heart disease, diabetes, cancer), resulting in a total score ranging from 0 to 33, if the patient had the most severe form of each of the 17 conditions.

    Measured: 2014 - 02/2025

  15. Laboratory parameters

    Routine laboratory value are collected. The specific parameters recorded may vary depending on the laboratory assessments documented in the patient register. All values will be reported using their respective units of measurement. These parameters are aggregated to support an overall clinical interpretation rather than a single numerical value. This approach reflects standard clinical practice, where multiple lab values are considered together to assess a patient's condition.

    Measured: 2014 - 02/2025

  16. Complications

    Complications occurring during intensive care treatment or clinical monitoring are collected, including but not limited to community-acquired and nosocomial infections, shock, hemorrhage, ischemic events, arrhythmia, cardiopulmonary arrest, and organ failure. These events are aggregated to provide a comprehensive overview of serious adverse clinical outcomes during critical care rather than reported as isolated parameters.

    Measured: 2014 - 02/2025

  17. Glasgow Outcome Score

    The Glasgow Outcome Score (GOS) is calculated based on the assessment of key clinical outcomes such as inhospital mortality, survival, survival with neurofunctional alteration, return to premorbid neurological function, and hospital readmission to determine the patient outcome.

    The GOS ranges from 1 (death) to 5 (good recovery).

    Measured: 2014 - 02/2025

  18. Therapeutic intervention

    Therapeutic interventions are documented, including duration, dosage, and number of medications, the number of drugs, administration of fluids (including blood products, crystalloids, enteral and parenteral nutrition, etc.), invasive procedures (such as intubation, mechanical ventilation, vasopressor use, and placement of central lines), and changes to any of these treatments, including the date of treatment adaptation.

    Measured: 2014 - 02/2025

  19. Vital signs

    Vital signs are analyzed based on the data available in the patient register. The specific parameters recorded depend on the clinical documentation available.These values are aggregated to support an overall clinical assessment rather than a single numerical score. This reflects standard practice, where multiple vital signs are interpreted together to evaluate a patient's condition.

    Measured: 2014 - 02/2025

  20. Comprehensive assessment of the neurological status based on Sedation-Agitation Scale (SAS)

    Neurological status during ICU stay is assessed using available data in the patient register from validated neurological assessments. These may include the Richmond Agitation-Sedation Scale (RASS), Sedation-Agitation Scale (SAS), Glasgow Coma Scale (GCS), or Intensive Care Delirium Screening Checklist (ICDSC). The specific tool used, as well as the scale of the score and meaning behind the score, depends on routine clinical practice and available documentation in the register. If multiple scores are available for a patient, they will be aggregated to provide a comprehensive assessment of neurological status. This outcome will be reported as a descriptive summary, synthesizing findings across tools, rather than as a single quantitative score. The sedation-Agitation Scale is a tool to assess both levels of sedation and agitation. In this tool scores 1-2 are for unawake patients and doesn't request use of sedative, while 3-7 are awake patients of which 5-7 are in need of Sedative use.

    Measured: 2014 - 02/2025

  21. Comprehensive assessment of the neurological status based on Glasgow Coma Scale (GCS)

    Neurological status during ICU stay is assessed using available data in the patient register from validated neurological assessments. These may include the Richmond Agitation-Sedation Scale (RASS), Sedation-Agitation Scale (SAS), Glasgow Coma Scale (GCS), or Intensive Care Delirium Screening Checklist (ICDSC). The specific tool used, as well as the scale of the score and meaning behind the score, depends on routine clinical practice and available documentation in the register. The Glasgow Coma Scale (GCS) is a standardized neurological tool used to objectively measure and track a person's level of consciousness, particularly following traumatic brain injury. It assesses three components:eye opening (1-4), verbal response (1-5), motor response (1-6), where higher scores indicate better function.

    Measured: 2014 - 02/2025

  22. Comprehensive assessment of the neurological status based on Comprehensive assessment of the neurological status based on Intensive Care Delirium Screening Checklist (ICDSC)

    Neurological status during ICU stay is assessed using available data in the patient register from validated neurological assessments. These may include the Richmond Agitation-Sedation Scale (RASS), Sedation-Agitation Scale (SAS), Glasgow Coma Scale (GCS), or Intensive Care Delirium Screening Checklist (ICDSC). The specific tool used, as well as the scale of the score and meaning behind the score, depends on routine clinical practice and available documentation in the register. The Intensive Care Delirium Screening Checklist (ICDSC) is an 8-item, validated tool used by ICU bedside nurses to rapidly screen for delirium in critically ill patients, including those who are intubated. It assesses behavioral, cognitive, and physiological symptoms over a 12-to-24-hour period, with a total score of indicating the presence of delirium.

    Measured: 2014 - 02/2025

  23. Comprehensive assessment of critical illness severity based on standardized scoring systems, including the Simplified Acute Physiology Score II (SAPS II)

    Disease severity during ICU stay is assessed using standardized scoring systems, including the Acute Physiology and Chronic Health Evaluation II (APACHE II), Simplified Acute Physiology Score II (SAPS II), and Sequential Organ Failure Assessment (SOFA), depending on data availability in the patient register. The specific scoring system applied, as well as the scale and interpretation of the score, varies based on routine clinical practice and available documentation. Where multiple severity scores are available, they will be synthesized to provide a descriptive summary of overall illness severity rather than a single quantitative score. The Simplified Acute Physiology Score II (SAPS II) is a severity-of-illness scoring system that estimates the risk of in-hospital mortality for adult ICU patients. Assessed within the first 24 hours of admission, it assigns 0-163 points based on age, admission type, chronic diseases, and 12 physiological variables

    Measured: 2014 - 02/2025

  24. Comprehensive assessment of critical illness severity based on standardized scoring systems, including the Sequential Organ Failure Assessment (SOFA)

    Disease severity during ICU stay is assessed using standardized scoring systems, including the Acute Physiology and Chronic Health Evaluation II (APACHE II), Simplified Acute Physiology Score II (SAPS II), and Sequential Organ Failure Assessment (SOFA), depending on data availability in the patient register. The specific scoring system applied, as well as the scale and interpretation of the score, varies based on routine clinical practice and available documentation. Where multiple severity scores are available, they will be synthesized to provide a descriptive summary of overall illness severity rather than a single quantitative score. The Sequential Organ Failure Assessment (SOFA) evaluates six organ systems (respiratory, cardiovascular, hepatic, coagulation, renal, and neurological), with scores ranging from 0 to 4 per system.

    Measured: 2014 - 02/2025

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2026
  2. Study start1 Jan 2014
  3. Primary completion28 Feb 2025
  4. Study completion28 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
800 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07441434
Sponsor's protocol ID
2025-00337; am25Sutter5
Other IDs
2025
Status last verified
Feb 2026
First submitted
10 Feb 2026
Last updated
2 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Neurologic Dysfunction, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient demographics (time frame: 2014 - 02/2025). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.

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