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Automated Pupillometry for Coma Prognostication After Cardiac Arrest

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ClinicalTrials.gov Identifier: NCT02607878
Recruitment Status : Completed
First Posted : November 18, 2015
Last Update Posted : April 2, 2018
Sponsor:
Collaborators:
Erasme University Hospital
Azienda Ospedaliera San Gerardo di Monza
Lund University Hospital
University Hospital, Grenoble
Catholic University of the Sacred Heart
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Cochin Hospital, India
Charite University, Berlin, Germany
Centre Hospitalier du Luxembourg
Information provided by (Responsible Party):
Mauro ODDO, Centre Hospitalier Universitaire Vaudois

Brief 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.


Condition or disease
Cardiac Arrest Comatose

Detailed Description:

Study: Prospective, multicenter study. The study will be double-blinded, i.e. the clinician/nurse performing the tests will not be involved in patient care and clinicians in charge of patients will not be aware of automated pupillometry data. Patient care will not be influenced by pupillometry.

Patient population:

The investigators plan to include 500 comatose post-CA patients. The centers have been selected based on their expertise and publication track record on the topic, and because they are actively involved in the Neurointensive Care section (NIC) of the European Society of Intensive Care Medicine (ESICM). The study will take place at the Department of Intensive Care of the participating centers.

Patients will be managed according to standards of post-resuscitation care and based on local algorithms for the treatment of post-CA coma.

Quantitative pupillary light reactivity (PLR, using the NeurOptics NPi-200 pupillometer) will be performed on ICU admission and then every 12 hours up to 72 hours after CA. At each time point, one measurement will be assessed on both eyes.

The primary variables for analysis will be the neurological pupil index (NPi) and the pupil size for both eyes. Standard PLR using a manual pen light will be performed simultaneously at each time point, as part of standard care.

EEG, SSEP and sampling for serum neuron specific enolase (NSE) will be performed at 24h and at 48-72h, according to local practices and as part of standard care.

The predictive value of NPi will be analyzed using the area under the receiving operator characteristics (ROC) curve, and compared to that of standard PLR, EEG, SSEP and NSE: sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), unweighted accuracy, with 95% binomial confidence intervals, will be calculated. Associations with outcome will adjusted for main baseline demographics (age, initial CA arrest rhythm, time from CA to tROSC), dose of sedation-analgesia and vaso-active agents, and the SOFA score, using a logistic regression model.


Study Type : Observational
Actual Enrollment : 470 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Automated Pupillometry for Coma Prognostication After Cardiac Arrest
Actual Study Start Date : January 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest Coma
U.S. FDA Resources




Primary Outcome Measures :
  1. Neurological outcome [ Time Frame: 3-6 months ]
    Neurological outcome is assessed by a semi-structured telephone interview with the patient or the patient's relatives using the Glasgow-Pittsburgh Cerebral Performance Categories (CPC). The CPC result is then categorized as favorable outcome (CPC 1-2, including good recovery and moderate disability), vs. unfavorable outcome (CPC 3-5, including severe disability, vegetative state and death).



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with coma after cardiac arrest (CA)
Criteria

Inclusion Criteria:

  • Adult patients with coma after cardiac arrest (CA)
  • Glasgow Coma Scale (at inclusion): ≤ 6
  • Patients with CA due to ventricular fibrillation (VF) and non-VF (including asystole and pulseless electrical activity) rhythms
  • Cardiac and non-cardiac causes of CA will be included

Exclusion Criteria:

  • Age < 18 years
  • Unable to obtain consent
  • Follow-up unavailable

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02607878


Locations
Belgium
Erasme University Hospital
Brussels, Belgium
France
University Hospital, Grenoble
Grenoble, France
Cochin Hospital
Paris, France
Germany
Charite University, Berlin, Germany
Berlin, Germany
Italy
Azienda Ospedaliera San Gerardo di Monza
Monza, Italy
Catholic University of the Sacred Heart
Roma, Italy
Luxembourg
Centre Hospitalier du Luxembourg
Luxembourg, Luxembourg
Netherlands
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Amsterdam, Netherlands
Sweden
Lund University Hospital
Lund, Sweden
Switzerland
CHUV, Lausanne University Hospital
Lausanne, Switzerland
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Erasme University Hospital
Azienda Ospedaliera San Gerardo di Monza
Lund University Hospital
University Hospital, Grenoble
Catholic University of the Sacred Heart
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Cochin Hospital, India
Charite University, Berlin, Germany
Centre Hospitalier du Luxembourg
Investigators
Principal Investigator: Mauro Oddo, MD CHUV, Lausanne University Hospital, Switzerland

Responsible Party: Mauro ODDO, Médecin adjoint, PD-MER I, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT02607878     History of Changes
Other Study ID Numbers: 432/14
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mauro ODDO, Centre Hospitalier Universitaire Vaudois:
Cardiac arrest
Coma
Prognosis
Automated pupillometry
EEG
Evoked potentials
Targeted Temperature Management (TTM)

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases