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

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University Hospital Basel

Status

Enrolling

Conditions

Adults
Brain Death

Treatments

Diagnostic Test: non-invasive device-supported, automated pupillometry

Study type

Observational

Funder types

Other

Identifiers

NCT06279975
Req-2023-01275 am23Sutter2;

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial contacts and locations

2

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Central trial contact

Pascale S Grzonka, MD; Raoul Sutter, Prof.

Data sourced from clinicaltrials.gov

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