NCT06279975

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Brain Death
• Adults

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-12-18
• Primary completion: 2029-12-01
• Completion: 2030-12-01
• First posted: 2024-02-28
• Last updated: 2025-03-12

Locations

2 sites across 1 country: Switzerland