Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02607878 |
Other study ID # |
432/14 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
January 2015 |
Est. completion date |
July 2017 |
Study information
Verified date |
September 2021 |
Source |
Centre Hospitalier Universitaire Vaudois |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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.