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

Recruiting

• Conditions: Brain Death; Adults

• Registration Number: NCT06279975
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

This prospective quality control study will evaluate the reliability of the clinical exam regarding pupils' reaction to light (as performed by two board certified physicians in Neurology and/or Intensive Care Medicine) as recommended by the SAMW guidelines for brain death diagnosis (SAMW-guidelines) when compared to the results of a noninvasive automated and highly-precise pupillometry in adult patients with clinically suspected brain death. Automated pupillometric measurements will be performed by the PI (RS), or the co-investigator (Dr. Pascale Grzonka) using the NeurOptics® NPi®-200 pupillometer system immediately before and after the standardized diagnostic workup for suspected brain death. In addition, demographics, clinical characteristics , treatment and laboratory data from the patients examined will be anonymously collected.

Study Timeline

• Study First Submitted: 2023-11-22
• Study Start: 2023-12-18
• Study First Submitted QC: 2024-02-22
• Study First Posted: 2024-02-28
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12
• Primary Completion: 2029-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reliability of clinical examination of pupils in patients with suspected brain death	baseline (2 hours before start of brain death evaluation) and 5 hours (2 hours after end of brain death evaluation)	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)

Trial Locations

Locations (2)

Intensive care unit at the University Hospital Basel; 🇨🇭 Basel, Basel-Stadt, Switzerland

University Hospital Basel; 🇨🇭 Basel, Switzerland