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

NCT06279975 — Recruiting, 50 participants, University Hospital, Basel, Switzerland

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Investigative Neurological Study With Pupillometric Evaluation os a Clinical Tool in Patients Declared Brain Dead (INSPECT) - a Prospective Quality Control Study

Registry	NCT06279975, acronym INSPECT
Status	Recruiting
Study type	Observational
Enrollment	50 (Estimated)
Sponsor	University Hospital, Basel, Switzerland (Other)
Conditions	Brain Death, Adults
Interventions	non-invasive device-supported, automated pupillometry (Diagnostic test)
Dates	start 2023-12-18, primary completion 2029-12-01 (estimated), completion 2030-12-01 (estimated), first posted 2024-02-28, last updated 2026-06-17
Locations	2 sites in Switzerland

-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.

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+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.

+Arms and 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

+Outcome measures

Primary outcomes

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)

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

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

+Locations (2)

Facility	City	Country	Status
Intensive care unit at the University Hospital Basel	Basel, Canton of Basel-City	Switzerland	Recruiting
University Hospital Basel	Basel	Switzerland	Recruiting

+Investigators

Raoul Sutter, Prof., Principal investigator, University Hospital, Basel, Switzerland