Anisocoria in the Intensive Care Unit (AICU Study)

NCT06964997 | Active Not Recruiting

• 1 other identifier: 2024-02347; am25Sutter3
• Study Type: observational
• Target: 920
• Locations: 1 country
• Sites: 1

Brief Summary

This retrospective single-center cohort study aims to determine the prevalence of acute "new onset" pupillary abnormalities in adult intensive care unit patients, assess their clinical impact, identify the contexts leading to treatment changes, and evaluate their prognostic implications.

Conditions

Anisocoria

Keywords

Pupillary abnormality; Intensive care unit

Outcome Measures

Primary Outcomes (18)

• 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.

  2013-2024

• Duration of intensive care unit stay

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

  2013-2024

• Duration of hospital stay

  The length of the total hospital stay is recorded.

  2013-2024

• Discharge destination

  The destination at discharge is recorded.

  2013-2024

• Date of incident

  The date when acute "new onset" pupillary abnormalities were first documented in patient records is recorded.

  2013-2024

• Characteristics of incident

  Details on the pupillary abnormality as described in nurses' and physicians' progress notes (e.g. wording) to characterize the condition.

  2013-2024

• Type of incident

  The type of pupillary abnormality (anisocoria, areactivity, or altered reaction to light) is recorded.

  2013-2024

• Additional features of the incident

  Assessment of additional features related to incident of pupillary abnormality (shift type, time of day (daytime or nighttime), and environment). These features are aggregated to characterize the context in which the assault occurred.

  2013-2024

• Patient characteristics

  Information on the patient (e.g., principal diagnosis, comorbidities, medication) is documented.

  2013-2024

• Consequences of the Incident

  Evaluation of medical assessments and interventions following the incident, including Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scans, ophthalmologic or neurologic consultations.

  2013-2024

• Comprehensive assessment of the neurological status based on validated clinical assessment

  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), Intensive Care Delirium Screening Checklist (ICDSC), or Status Epilepticus Severity Score (STESS). 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.

  2013-2024

• Comprehensive assessment of critical illness severity based on standardized scoring 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.

  2013-2024

• 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.

  2013-2024

• Laboratory parameters

  Routine laboratory value for e.g. C-Reactive Protein (CRP), albumin, Lactate Dehydrogenase (LDH), Creatine Kinase (CK), procalcitonin, white blood cell levels, creatinine, liver enzymes, blood gas analyses, metabolic data, and toxicologic screenings, is 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.

  2013-2024

• 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).

  2013-2024

• Therapeutic intervention

  The therapeutic intervention is document, including information on duration, dosage and number of treatment medication, number of neuroleptic, sedative and analgesic drugs, use of ipratropium bromide, invasive procedures, such as intubation, mechanical, ventilation, vasopressors, installation of central lines, i.v. thrombolysis, endovascular thrombectomy, surgical hemicraniectomy, insertion of ventricular drains, intracranial pressure monitoring, i.v. administration of mannitol or saline, nutrition, etc.

  2013-2024

• Vital signs

  Vital signs are analyzed based on the data available in the patient register. These may include blood pressure, heart rate, respiratory rate, oxygen saturation, body temperature, level of consciousness, intracranial pressure, and drainage rate of cerebrospinal fluid. The specific parameters recorded depend on the clinical documentation available. All values will be reported using their respective units of measurement. 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.

  2013-2024

• Fluid balance data

  Fluid balance data, including the administration of fluids such as blood products, crystalloids, and enteral/parenteral nutrition, are documented. These components are aggregated to represent overall fluid input for each patient.

  2013-2024

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients (i.e., patients ≥18 years of age) with a reported incident of pupillary abnormality (either anisocoria or non-normal pupillary reactivity) in the intensive care unit at the University Hospital Basel between 2013-2024.

You may qualify if:

• Adult patients (i.e., patients ≥18 years of age)
• Reported incident of pupillary abnormality (either anisocoria or non-normal pupillary reactivity) in the intensive care unit at the University Hospital Basel between 2013-2024.

You may not qualify if:

• Patients younger than 18 years
• Patients with documented refusal of data use.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel, Clinic for Intensive Care Medicine

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Conditions

Anisocoria

Condition Hierarchy (Ancestors)

Pupil Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Raoul Sutter, Prof. Dr. med.

  University Hospital Basel, Clinic for Intensive Care Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: May 11, 2025
• Study Start: March 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 11, 2025

Record last verified: 2025-04

Locations

CH (1)