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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
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Intensive care unit at the University Hospital Basel
Basel, Canton of Basel-City, Switzerland
University Hospital Basel
Basel, Switzerland
Start Date
December 18, 2023
Primary Completion Date
December 1, 2029
Completion Date
December 1, 2030
Last Updated
March 12, 2025
50
ESTIMATED participants
non-invasive device-supported, automated pupillometry
DIAGNOSTIC_TEST
Lead Sponsor
University Hospital, Basel, Switzerland
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07252687