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

Brain Death Clinical Trial

— INSPECT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06279975
• Other study ID #: Req-2023-01275; am23Sutter2
• Status: Recruiting
• Start date: December 18, 2023
• Est. completion date: December 2030

Study information

• Verified date: February 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Raoul Sutter, Prof.
• Phone: +41 61 32 87928
• Email: raoul.sutter[@]usb.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2030
• Est. primary completion date: December 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Adults
• Brain Death

Intervention

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

Locations

Country	Name	City	State
Switzerland	Intensive care unit at the University Hospital Basel	Basel	Basel-Stadt
Switzerland	University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	baseline (2 hours before start of brain death evaluation) and 5 hours (2 hours after end of brain death evaluation)