Automated Pupillometry for Coma Prognostication After Cardiac Arrest

Summary

Background: Sedation and therapeutic hypothermia (TH) delay neurological responses and might reduce the accuracy of clinical examination to predict outcome after cardiac arrest (CA). Electroencephalography (EEG) and somato-sensory evoked potentials (SSEP) might significantly improve prognostication of post-CA coma, however, EEG and SSEP are not always available and require specific expertise for their interpretation. Automated video pupillometry is a novel electronic device that contains an infrared light camera which enables to measure quantitatively the percentage of pupillary reaction to a calibrated light stimulation. In a recent study of a cohort of comatose CA survivors (n=50 patients) it was found that quantitative PLR was more accurate than standard PLR (manual pen light) in predicting 3-month outcome, irrespective of temperature and sedation, and had comparable prognostic accuracy than electrophysiological exams, including electroencephalography (EEG) and somato-sensory evoked potentials (SSEP).

Aim of the study: In light of these promising results, the investigators would like to confirm the prognostic value of quantitative PLR in a large multicenter cohort of comatose post-CA patients.

Design of the study: Prospective, multicenter, observational outcome trial.

Conditions

• Cardiac Arrest
• Comatose

Sponsors & Collaborators

• Erasme University Hospital

  collaborator OTHER

• Azienda Ospedaliera San Gerardo di Monza

  collaborator OTHER

• Lund University Hospital

  collaborator OTHER

• University Hospital, Grenoble

  collaborator OTHER

• Catholic University of the Sacred Heart

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• Cochin University Hospital, Paris

  collaborator UNKNOWN

• Charite University, Berlin, Germany

  collaborator OTHER

• Centre Hospitalier du Luxembourg

  collaborator OTHER

• Centre Hospitalier Universitaire Vaudois

  lead OTHER

Principal Investigators

• Mauro Oddo, MD · CHUV, Lausanne University Hospital, Switzerland

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-31

Primary Completion

2017-03-31

Completion

2017-07-31

Countries

• Belgium
• France
• Germany
• Italy
• Luxembourg
• Netherlands
• Sweden
• Switzerland

Study Locations