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RecruitingNCT06279975INSPECTUpdated Jun 17, 2026

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

An observational study in Brain Death and Adults, sponsored by University Hospital, Basel, Switzerland. Recruiting at 2 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-17.

Sponsored by University Hospital, Basel, Switzerland · Observational

From the registry’s dates

  • Started Dec 2023; still recruiting 2 years 10 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Brain Death
  • Adults

Keywords

  • Pupillometry
  • Brain Death
  • Diagnosis
03

In context

Brain Death

74 studies on the registry are indexed under Brain Death; 10 are open to participants now.

This study's planned enrollment of 50 is below the median of 80 across 33 observational studies indexed under Brain Death.

Browse Brain Death studies →

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 990 studies on the registry; 189 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Eligibility 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)
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testnon-invasive device-supported, automated pupillometry

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

06

What researchers measure

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)

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

07

Study locations

2 of 2 sites recruiting
  • Intensive care unit at the University Hospital Basel
    Basel, Canton of Basel-City 4031, Switzerland
    Recruiting
    • Raoul Sutter, Prof. · Contactraoul.sutter@usb.ch · +41 61 328 7928
    • Raoul Sutter, Prof. · Principal investigator
    • Pascale Grzonka, MD · Sub investigator
  • University Hospital Basel
    Basel, Switzerland
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06279975
Responsible party
Sponsor
First posted
Feb 28, 2024
Start date
Dec 18, 2023
Primary completion
Dec 2029 (estimated)
Completion
Dec 2030 (estimated)
Last update
Jun 17, 2026

Study contacts

Raoul Sutter, Prof.
Contact
raoul.sutter@usb.ch
+41 61 32 87928
Pascale S Grzonka, MD
Contact
PascaleSusanne.Grzonka@usb.ch
+41 61 32 84076
Raoul Sutter, Prof.
principal investigator · University Hospital, Basel, Switzerland

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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