Pupillometric Evaluation in Patients Declared Brain Dead - a Prospective Quality Control Study

NCT06279975 | Recruiting

• 1 other identifier: Req-2023-01275; am23Sutter2
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the study is to verify the reliability of the current purely clinical examination of the pupils (without the support of a pupillometer) in the context of clinically suspected brain death, compared to the results of a non-invasive, automated, and highly precise monocular pupillometric examination.

Conditions

Brain Death; Adults

Keywords

Pupillometry; Brain Death; Diagnosis

Outcome Measures

Primary Outcomes (1)

• Reliability of clinical examination of pupils in patients with suspected brain death

  Determination of the reliability of the current purely clinical examination of the pupils (without the support of a pupillometer) in the context of clinically suspected brain death compared to the results of a noninvasive, automated, and highly precise pupillometric examination (measurement of the discordance between automated analyses of pupillary light reflex by a hand-held pupillometer and visual examination without pupillometer support in percentage)

  baseline (2 hours before start of brain death evaluation) and 5 hours (2 hours after end of brain death evaluation)

Interventions

non-invasive device-supported, automated pupillometry DIAGNOSTIC_TEST

non-invasive device-supported, automated pupillometry with a precise quantitative measurement of the pupils within the range of micrometers

Eligibility Criteria

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

Study Population

The patient population is defined as all adult patients (i.e. ≥18 years of age) treated on the intensive care unit at the University Hospital Basel (USB) in whom the treating physicians suspect brain death and plan to perform brain death diagnostic procedures.

You may qualify if:

• Suspected diagnosis of brain death
• Brain death diagnostic procedures planned
• Treated at the intensive care unit at the University Hospital Basel (USB)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (2)

Intensive care unit at the University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

RECRUITING

University Hospital Basel

Basel, Switzerland

RECRUITING

MeSH Terms

Conditions

Brain Death; Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Coma; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Raoul Sutter, Prof.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raoul Sutter, Prof.

CONTACT

+41 61 32 87928; raoul.sutter@usb.ch

Pascale S Grzonka, MD

CONTACT

+41 61 32 84076; PascaleSusanne.Grzonka@usb.ch

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: February 28, 2024
• Study Start: December 18, 2023
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)