Cardiac ArrestNCT02607878
Automated Pupillometry for Coma Prognostication After Cardiac Arrest
An observational study of Cardiac Arrest and Comatose, run by Centre Hospitalier Universitaire Vaudois at 10 sites in 8 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Comatose
- How many people
- 470 participants
- Where
- 10 sitesin 8 countries
- Study dates
- Jan 2015to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with coma after cardiac arrest (CA)
Who may be able to join
- 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
Who cannot join
- Age < 18 years
- Unable to obtain consent
- Follow-up unavailable
Trial locations and contacts
10 sites in 8 countries.
10 sites in 8 countries
Italy2 sites
Azienda Ospedaliera San Gerardo di Monza
Monza
Catholic University of the Sacred Heart
Roma
Netherlands1 site
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Amsterdam
About this study
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.
Read the 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.
- Conditions
- Cardiac Arrest, Comatose
- Keywords
- Cardiac arrest, Coma, Prognosis, Automated pupillometry, EEG, Evoked potentials, Targeted Temperature Management (TTM)
- Medical subject headings
- Heart Arrest, Coma
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological outcome
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).
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study startJan 2015
- Primary completionMar 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- 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), Hôpital Cochin, Charite University, Berlin, Germany, Centre Hospitalier du Luxembourg
- Responsible party
- Principal investigator, Mauro ODDO, Centre Hospitalier Universitaire Vaudois
- Investigators
- Mauro Oddo, MD, Principal investigator, CHUV, Lausanne University Hospital, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607878
- Sponsor's protocol ID
- 432/14
- Status last verified
- Sep 2021
- First submitted
- 2 Nov 2015
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Pupillometry for Coma Prognostication After Cardiac Arrest
- ClinicalTrials.gov ID
- NCT02607878
- Acronym / sponsor ID
- 432/14
- Conditions
- Cardiac Arrest, Comatose
- Keywords
- Cardiac arrest, Coma, Prognosis, Automated pupillometry, EEG, Evoked potentials, Targeted Temperature Management (TTM)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- 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), Hôpital Cochin, Charite University, Berlin, Germany, Centre Hospitalier du Luxembourg
- Study start
- Jan 2015 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 18 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coma after cardiac arrest (CA)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Age < 18 years
- Unable to obtain consent
- Follow-up unavailable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mauro Oddo, MD principal investigator
CHUV, Lausanne University Hospital, Switzerland
10 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest and Comatose, run by Centre Hospitalier Universitaire Vaudois at 10 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France, Italy, Belgium, Germany, Luxembourg and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological outcome (time frame: 3-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.