Pupillometric Evaluation in Patients Declared Brain Dead - a Prospective Quality Control Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: non-invasive device-supported, automated pupillometry.
- Who it may be relevant to
- Registry conditions: Brain Death, Adults. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Investigative Neurological Study With Pupillometric Evaluation os a Clinical Tool in Patients Declared Brain Dead (INSPECT) - a Prospective Quality Control Study
Overview
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.
Interventions
- Diagnostic test non-invasive device-supported, automated pupillometry
non-invasive device-supported, automated pupillometry with a precise quantitative measurement of the pupils within the range of micrometers
Primary outcome measures
- 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)]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Switzerland · 2 centers
- Intensive care unit at the University Hospital Basel — Basel
- University Hospital Basel — Basel
Identifiers
NCT: NCT06279975 · Req-2023-01275; am23Sutter2