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

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.

Recruiting

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Intensive care unit at the University Hospital Basel, Basel, Canton of Basel-City, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

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

Primary outcomes

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

Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Pascale S Grzonka, MD

CONTACT

[email protected]

+41 61 32 84076

Raoul Sutter, Prof.

CONTACT

[email protected]

+41 61 32 87928

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: INSPECT

Important dates

Study start: 2023
Primary completion: 2029
Study completion: 2030
First posted: Feb 28, 2024
Registry last updated: Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed