Cardiac ArrestCAPPINCT04336930
Evaluation of the "Pupillary Pain Index" in Neurological Prognosis After Cardiac Arrest
An observational study of Cardiac Arrest and Post-Anoxic Coma, run by Central Hospital, Nancy, France.
Trial summary
Two-thirds of patients admitted to the Intensive Care Unit after a cardiac arrest die in the context of treatment withdrawal after a multimodal evaluation that determines an unfavorable neurological outcome. This study will evaluate the Pupillary Pain Index (PPI) in the neurological prognosis after cardiac arrest. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Post-Anoxic Coma, Anoxic Brain Injury
- What is being tested?
- Pupillary pain index (PPI)
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 1 Jul 2023
- 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 remaining comatose after cardiac arrest
Who may be able to join
- Admission to the ICU after cardiac arrest
- Age > 18 years
- Presenting a Glasgow score of <8 at admission
Who cannot join
- Pregnancy
- Ocular pathology making pupillometry impossible.
- Patient under guardianship or curatorship
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the Pupillary Dilatation Reflex With the "Pupillary Pain Index" in Neurological Prognosis After Cardiac Arrest
Two-thirds of patients admitted to the Intensive Care Unit after a cardiac arrest die in the context of treatment withdrawal after a multimodal evaluation that determines an unfavorable neurological outcome.
This study will evaluate the Pupillary Pain Index (PPI) in the neurological prognosis after cardiac arrest. The PPI is determined by recording of pupillary dilatation with a videopupillometer after a calibrated and incremented nociceptive stimulus on a cutaneous metamere.
Read the detailed description
Cardiorespiratory arrest is associated with high mortality and morbidity rates. The direct consequence of a cardio-circulatory arrest is the absence of blood flow allowing oxygenation of the organs and consequently formation of ischemic lesions. Anoxic cerebral lesions are common in the aftermath of a cardiac arrest and often lead to the death of patients when active therapies are stopped after a multimodal prognostication that indicates that a poor outcome is very likely.
It is of paramount importance to optimize the sensitivity of the prognostication strategy in detecting good neurological outcome. A multimodal approach to the prognostic assessment is essential, and must include at least clinical examination, electrophysiology exploration (electroencephalography and/or evoked potentials) and biomarker analysis.
Although the most reliable predictors did not give false positives in most studies, none of them, considered individually, can establish an unfavorable prognosis with an absolute degree of certitude. For these reasons it is interesting to evaluate new prognostication tools.
The videopupillometry allows precise, reproducible and repeated measurement of changes in pupil diameter in response to a painful or a luminous stimulus. Pupillary pain reflex analysis is usually used to assess the degree of analgesia in a non-communicative patient during general anesthesia and neuromuscular blockade. The PPI score is determined at the bedside by recording pupillary dilatation after a calibrated and incremented nociceptive stimulus (electrical current between 5 and 60mA) applied to a skin metamere with two electrodes.
Automated pupillometry measurement has been recently developed to help support prognostication, with a quantitative pupillary light reflex measurement. The aim of this study is to evaluate the Pupillary Pain Index in the neurological prognosis after a cardiac arrest by correlating the PPI at 48h from the patient's arrival to the CPC score at 3 months.
- Conditions
- Cardiac Arrest, Post-Anoxic Coma, Anoxic Brain Injury
- Being tested
- Pupillary pain index (PPI)
- Keywords
- Pupillometry, Pupillary Pain Index, Brain ischemia, Heart arrest, Neuroprognostication
- Medical subject headings
- Heart Arrest, Hypoxia-Ischemia, Brain, Brain Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pupillary pain index (PPI)Diagnostic test
Measurement of PPI with a pupillometer
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Arrest group | Patients remaining comatose after a cardiac arrest Receives: Diagnostic Test: Pupillary pain index (PPI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score Cerebral Performance Category (CPC)
Good outcome defined as CPC 1-2, poor outcome defined as CPC 3-5
Measured: 3 months
Secondary outcomes (10)
Characteristics of electroencephalography pattern
Classification of Synek, type of pattern (Very malignant, malignant or benign)
Measured: Day 2, day 3, day 5, day 7
Biomarkers
Value of seric Neuron Specific Enolase
Measured: 24 hours, 48 hours
Glasgow motor score
Motor response component of the Glasgow Coma Scale, ranging from 1 (no response) to 6 (normal response)
Measured: 24 hours, 48 hours, day 5, day 7
ICU parameters
Ventilator days, Length of stay
Measured: Day 14
Evoked Potentials
Presence or absence of the N20 component of the evoked potentials
Measured: Day 14
Neurological pupil index
standardized evaluation of pupil reactivity ranging from 0 (sluggish or abnormal pupils) to 5 (normally reactive pupils)
Measured: Day 2, day 3
Diameter of the pupil
In millimeters (pupillometry measure)
Measured: 24 hours, 48 hours, 72 hours
Percentage of pupil dilatation
Pupillometry measure
Measured: 24 hours, 48 hours, 72 hours
Latency of pupil dilatation
In milliseconds (pupillometry measure)
Measured: 24 hours, 48 hours, 72 hours
Velocity of pupil dilatation
In millimeters per second (pupillometry measure)
Measured: 24 hours, 48 hours, 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start1 Nov 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion1 Jul 2023 (estimated)
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.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthieu Koszutski, Dr, Principal investigator, Nancy Teaching Hospital, CHU de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336930
- Sponsor's protocol ID
- 2019PI275
- Acronym
- CAPPI
- Status last verified
- May 2021
- First submitted
- 10 Mar 2020
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Pupillary Dilatation Reflex With the "Pupillary Pain Index" in Neurological Prognosis After Cardiac Arrest
- ClinicalTrials.gov ID
- NCT04336930
- Acronym / sponsor ID
- CAPPI / 2019PI275
- Conditions
- Cardiac Arrest, Post-Anoxic Coma, Anoxic Brain Injury
- Keywords
- Pupillometry, Pupillary Pain Index, Brain ischemia, Heart arrest, Neuroprognostication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 7 Apr 2020 (actual)
- 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.
Two-thirds of patients admitted to the Intensive Care Unit after a cardiac arrest die in the context of treatment withdrawal after a multimodal evaluation that determines an unfavorable neurological outcome.
This study will evaluate the Pupillary Pain Index (PPI) in the neurological prognosis after cardiac arrest. The PPI is determined by recording of pupillary dilatation with a videopupillometer after a calibrated and incremented nociceptive stimulus on a cutaneous metamere.
Detailed description
Cardiorespiratory arrest is associated with high mortality and morbidity rates. The direct consequence of a cardio-circulatory arrest is the absence of blood flow allowing oxygenation of the organs and consequently formation of ischemic lesions. Anoxic cerebral lesions are common in the aftermath of a cardiac arrest and often lead to the death of patients when active therapies are stopped after a multimodal prognostication that indicates that a poor outcome is very likely.
It is of paramount importance to optimize the sensitivity of the prognostication strategy in detecting good neurological outcome. A multimodal approach to the prognostic assessment is essential, and must include at least clinical examination, electrophysiology exploration (electroencephalography and/or evoked potentials) and biomarker analysis.
Although the most reliable predictors did not give false positives in most studies, none of them, considered individually, can establish an unfavorable prognosis with an absolute degree of certitude. For these reasons it is interesting to evaluate new prognostication tools.
The videopupillometry allows precise, reproducible and repeated measurement of changes in pupil diameter in response to a painful or a luminous stimulus. Pupillary pain reflex analysis is usually used to assess the degree of analgesia in a non-communicative patient during general anesthesia and neuromuscular blockade. The PPI score is determined at the bedside by recording pupillary dilatation after a calibrated and incremented nociceptive stimulus (electrical current between 5 and 60mA) applied to a skin metamere with two electrodes.
Automated pupillometry measurement has been recently developed to help support prognostication, with a quantitative pupillary light reflex measurement. The aim of this study is to evaluate the Pupillary Pain Index in the neurological prognosis after a cardiac arrest by correlating the PPI at 48h from the patient's arrival to the CPC score at 3 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Arrest group | – | Diagnostic Test: Pupillary pain index (PPI)Patients remaining comatose after a cardiac arrest |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients remaining comatose after cardiac arrest
Key inclusion criteria (3 listed)
- Admission to the ICU after cardiac arrest
- Age > 18 years
- Presenting a Glasgow score of <8 at admission
Key exclusion criteria (3 listed)
- Pregnancy
- Ocular pathology making pupillometry impossible.
- Patient under guardianship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pupillary pain index (PPI)Measurement of PPI with a pupillometer | Diagnostic test | Cardiac Arrest group |
Primary outcome
Score Cerebral Performance Category (CPC)
Time frame: 3 months
Good outcome defined as CPC 1-2, poor outcome defined as CPC 3-5
10 secondary outcomes
Characteristics of electroencephalography pattern
Time frame: Day 2, day 3, day 5, day 7
Biomarkers
Time frame: 24 hours, 48 hours
Glasgow motor score
Time frame: 24 hours, 48 hours, day 5, day 7
ICU parameters
Time frame: Day 14
Evoked Potentials
Time frame: Day 14
Neurological pupil index
Time frame: Day 2, day 3
Diameter of the pupil
Time frame: 24 hours, 48 hours, 72 hours
Percentage of pupil dilatation
Time frame: 24 hours, 48 hours, 72 hours
Latency of pupil dilatation
Time frame: 24 hours, 48 hours, 72 hours
Velocity of pupil dilatation
Time frame: 24 hours, 48 hours, 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 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.
Matthieu Koszutski, Dr principal investigator
Nancy Teaching Hospital, CHU de Nancy
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest and Post-Anoxic Coma, run by Central Hospital, Nancy, France.
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 3 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: status not confirmed, as of the sponsor's last update on 24 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthieu KOSZUTSKI, Dr (+33383153017, m.koszutski@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score Cerebral Performance Category (CPC) (time frame: 3 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 24 May 2021.