Cardiac ArrestEASY-CARENCT05192772
Early Neurological Assessment With Pupillometry in Cardiac Arrest During Resuscitation
An observational study of Cardiac Arrest and Out-Of-Hospital Cardiac Arrest, run by Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva at 1 site in Italy.
Trial summary
Easy Care study wants to demonstrate a correlation between intra-CPR infrared quantitative pupillometry and return of spontaneous circulation (ROSC). Neurological pupil index (NPi) will be used alone and in association with end-tidal CO2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Out-Of-Hospital Cardiac Arrest
- What is being tested?
- NPi200
- Type of treatment
- Medical device
- How many people
- 214 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2022to 15 Dec 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: all adults present in the Lombardy region at the time of cardiac arrest.
Who may be able to join
- Not traumatic cardiac arrest in pre-hospital setting (OHCA)
- unexpected OHCA
- Lombardy region territory
Who cannot join
- Traumatic Brain injury
- Cerebrovascular emergecies at computer tomography (CT) scan after hospital admission
- Peripheral or cortical blindness
- One or both eyes loss
- Iris palsy or known peripheral anisocoria
- No indication for resuscitation
Trial locations and contacts
1 site in 1 country.
Frank A. Rasulo, Prof. contact
Italy1 site, 1 recruiting
- Recruiting
Agenzia Regionale Emergenza Urgenza - AREU
Milan, 20124
Simone M Zerbi, MD, +390315859742, s.zerbi@areu.lombardia.it
About this study
Official title: EASY CARE Early Neurological Assessment With Pupillometry in Cardiac Arrest During Resuscitation
Easy Care study wants to demonstrate a correlation between intra-CPR infrared quantitative pupillometry and return of spontaneous circulation (ROSC).
Neurological pupil index (NPi) will be used alone and in association with end-tidal CO2.
Read the detailed description
At the arrival of medicalised rescue team on the emergency scene, patient will be screened for including criteria. In case of eligibility pupillometry will be collected each eye in the following frame time:
- T 0: time of enrolling
- T 1: after first cycle of resuscitation (approximatively 2 minutes following guidelines)
- T 2 … Tn: every cycle of CPR (or every 2 minutes if intubated patient) bilateral pupillometry will be collected
- T end: the last pupillometry at ROSC time or death. All pupillometry mesures will be obtained from a technician not trained to interpret NPi index. This to maintain blindness during resuscitation efforts.
Data will be collected in anonymous web-based database passwords protected. For the survivors patients enrolled, data collecting continue in Intensive Care Unit (ICU) as neuroprognostication exams (biomarkers, imaging, neurophysiology). Blind follow up will be obtained from ICU as described in secondary outcome section
- Conditions
- Cardiac Arrest, Out-Of-Hospital Cardiac Arrest
- Being tested
- NPi200
- Medical subject headings
- Heart Arrest, Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPi200Device
Digital pupillometry performed during cardiopulmonary resuscutation (CPR) every CPR cycle end in case of not intubated patient, or every 2 minutes in case of intubated patient
What is being measured
The primary outcome is the main question the study is designed to answer.
Return of spontaneous circulation (ROSC) prediction
We are searching for possible correlation between pupillary reactivity (NPi) collected during resuscitation manoeuvres and ROSC. NPi is a numeric score ranges from 0 (unreactive pupils) and 5 (normal reflex).
Measured: Variable because depends on the cardiac resuscitation manoeuvers lasting usually not more than 45 minutes
Secondary outcomes (4)
Correlation of NPi and end tidal CO2 (ETCO2) and ROSC prediction
NPi meaning has been described previously, ETCO2 represents the amount of CO2 exhaled during ventilation in course of cardiopulmonary resuscitation. It represent a good indicator of tissues reperfusion.
We suppose that NPi could reflect the brainstem vitality. We want to demonstrate if the association between a well known indicator as ETCO2 and the NPi may emprove the ROSC prediction compared to NPi alone (primary objective).
Measured: Variable because depends on the cardiac resuscitation manoeuvers lasting usually not more than 45 minutes
Correlation between NPi and Neurological Outcome as Modified Rankin Scale (mRS)
association between pupillary reactivity (NPi) absence and poor neurological outcome. The outcome will be evaluated in using modified Rankin Scale range from 0 (no symptoms) to 6 (death). We will aggregate the outcome in a dichotomised result as: good outcome (mRS 0-4) and poor outcome (mRS 5-6).
The exams of patients will be performed at 1 month, 6 month (or hospital discharge) and 1 year from ROSC, and at ICU discharge.
The patients exams will be performed with a telephone interview about their fisical condition accordingly to mRS score description.
Measured: 1 month, 6 months, 1 year
Correlation between NPi trend and ROSC
We are searching for a possible correlation between the NPi trend during cardiac pulmonary resuscitation (CPR) and the ROSC. We suppose that an improvement of NPi values during CPR can indicate a progressive oxygenation and functionality of tissues with an increased probability of ROSC
Measured: Variable because depends on the cardiac resuscitation manoeuvers lasting usually not more than 45 minutes
Correlation between NPi trend and mRS in ROSC patients
Similarly to outcome 4, we suppose that a progressive improvement of NPi values during CPR may suggest vitality of the brainstem and oxigenation of the brain.
We want to evaluate possible correlation between changing in NPi trend and neurological outcome with mRS in the survivors patient (ROSC)
Measured: 1 month, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
- Sponsor type
- University, hospital or other
- Collaborators
- AREU - Agenzia Regionale Emergenza Urgenza
- Responsible party
- Principal investigator, Simone Maria Zerbi, Azienda Ospedaliera Sant'Anna
- Investigators
- Simone M Zerbi, MD, Principal investigator, ASST Lariana Ospedale Sant'Anna di ComoFrank A Rasulo, Prof., Study director, Division of Anesthesiology, Intensive Care & emergency Medicine, Università degli studi di BresciaMarco Botteri, MD, Study chair, AREU - Agenzia Regionale Emergenza UrgenzaClaudio Sandroni, Prof., Study chair, Institute of Anesthesiology and Intensive Care Medicine, Università Cattolica del Sacro Cuore, Roma.Giovanni Chiarini, MD, Study chair, Dip. Anestesia, Rianimazione ed Emergenze II, ASST Spedali Civili di BresciaMaurizio Raimondi, MD, Study chair, UOC Anestesia e Rianimazione Voghera e Oltrepò, ASST Pavia.Antonio Bellasi, phD, Study chair, Department of Medicine, Division of Nephrology, EOC, Lugano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192772
- Sponsor's protocol ID
- 2494
- Acronym
- EASY-CARE
- Status last verified
- Oct 2022
- First submitted
- 25 Nov 2021
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oddo M, Sandroni C, Citerio G, Miroz JP, Horn J, Rundgren M, Cariou A, Payen JF, Storm C, Stammet P, Taccone FS. Quantitative versus standard pupillary light reflex for early prognostication in comatose cardiac arrest patients: an international prospective multicenter double-blinded study. Intensive Care Med. 2018 Dec;44(12):2102-2111. doi: 10.1007/s00134-018-5448-6. Epub 2018 Nov 26.
PubMed 30478620Riker RR, Sawyer ME, Fischman VG, May T, Lord C, Eldridge A, Seder DB. Neurological Pupil Index and Pupillary Light Reflex by Pupillometry Predict Outcome Early After Cardiac Arrest. Neurocrit Care. 2020 Feb;32(1):152-161. doi: 10.1007/s12028-019-00717-4.
PubMed 31069659Achamallah N, Fried J, Love R, Matusov Y, Sharma R. Pupillary Light Reflex Is Not Abolished by Epinephrine and Atropine Given During Advanced Cardiac Life Support in Patients Who Achieve Return of Spontaneous Circulation. J Intensive Care Med. 2021 Apr;36(4):459-465. doi: 10.1177/0885066620906802. Epub 2020 Feb 18.
PubMed 32066312Lee HJ, Shin J, Hong KJ, Jung JH, Lee SJ, Jung E, You KM, Kim TH. A feasibility study for the continuous measurement of pupillary response using the pupillography during CPR in out-of-hospital cardiac arrest patients. Resuscitation. 2019 Feb;135:80-87. doi: 10.1016/j.resuscitation.2018.11.016. Epub 2018 Dec 30.
PubMed 30599180Zerbi SM, Sandroni C, Botteri M, Bellasi A, Latronico N, Rasulo F. Early Neurological ASsessment with pupillometrY during Cardiac Arrest REsuscitation (EASY-CARE): protocol for an observational multicentre prospective study. BMJ Open. 2022 Dec 20;12(12):e063633. doi: 10.1136/bmjopen-2022-063633.
PubMed 36600432
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EASY CARE Early Neurological Assessment With Pupillometry in Cardiac Arrest During Resuscitation
- ClinicalTrials.gov ID
- NCT05192772
- Acronym / sponsor ID
- EASY-CARE / 2494
- Conditions
- Cardiac Arrest, Out-Of-Hospital Cardiac Arrest
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Societa Italiana Anestesia Analgesia Rianimazione e Terapia IntensivaUniversity, hospital or other
- Collaborators
- AREU - Agenzia Regionale Emergenza Urgenza
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 14 Jan 2022 (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.
Easy Care study wants to demonstrate a correlation between intra-CPR infrared quantitative pupillometry and return of spontaneous circulation (ROSC).
Neurological pupil index (NPi) will be used alone and in association with end-tidal CO2.
Detailed description
At the arrival of medicalised rescue team on the emergency scene, patient will be screened for including criteria. In case of eligibility pupillometry will be collected each eye in the following frame time:
- T 0: time of enrolling
- T 1: after first cycle of resuscitation (approximatively 2 minutes following guidelines)
- T 2 … Tn: every cycle of CPR (or every 2 minutes if intubated patient) bilateral pupillometry will be collected
- T end: the last pupillometry at ROSC time or death. All pupillometry mesures will be obtained from a technician not trained to interpret NPi index. This to maintain blindness during resuscitation efforts.
Data will be collected in anonymous web-based database passwords protected. For the survivors patients enrolled, data collecting continue in Intensive Care Unit (ICU) as neuroprognostication exams (biomarkers, imaging, neurophysiology). Blind follow up will be obtained from ICU as described in secondary outcome section
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
- all adults present in the Lombardy region at the time of cardiac arrest.
Key inclusion criteria (3 listed)
- Not traumatic cardiac arrest in pre-hospital setting (OHCA)
- unexpected OHCA
- Lombardy region territory
Key exclusion criteria (6 listed)
- Traumatic Brain injury
- Cerebrovascular emergecies at computer tomography (CT) scan after hospital admission
- Peripheral or cortical blindness
- One or both eyes loss
- Iris palsy or known peripheral anisocoria
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 |
|---|---|---|
| NPi200Digital pupillometry performed during cardiopulmonary resuscutation (CPR) every CPR cycle end in case of not intubated patient, or every 2 minutes in case of intubated patient | Device | – |
Primary outcome
Return of spontaneous circulation (ROSC) prediction
Time frame: Variable because depends on the cardiac resuscitation manoeuvers lasting usually not more than 45 minutes
We are searching for possible correlation between pupillary reactivity (NPi) collected during resuscitation manoeuvres and ROSC. NPi is a numeric score ranges from 0 (unreactive pupils) and 5 (normal reflex).
4 secondary outcomes
Correlation of NPi and end tidal CO2 (ETCO2) and ROSC prediction
Time frame: Variable because depends on the cardiac resuscitation manoeuvers lasting usually not more than 45 minutes
Correlation between NPi and Neurological Outcome as Modified Rankin Scale (mRS)
Time frame: 1 month, 6 months, 1 year
Correlation between NPi trend and ROSC
Time frame: Variable because depends on the cardiac resuscitation manoeuvers lasting usually not more than 45 minutes
Correlation between NPi trend and mRS in ROSC patients
Time frame: 1 month, 6 months, 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Background: PubMed 30478620Oddo M, Sandroni C, Citerio G, Miroz JP, Horn J, Rundgren M, Cariou A, Payen JF, Storm C, Stammet P, Taccone FS. Quantitative versus standard pupillary light reflex for early prognostication in comatose cardiac arrest patients: an international prospective multicenter double-blinded study. Intensive Care Med. 2018 Dec;44(12):2102-2111. doi: 10.1007/s00134-018-5448-6. Epub 2018 Nov 26.
- Background: PubMed 31069659Riker RR, Sawyer ME, Fischman VG, May T, Lord C, Eldridge A, Seder DB. Neurological Pupil Index and Pupillary Light Reflex by Pupillometry Predict Outcome Early After Cardiac Arrest. Neurocrit Care. 2020 Feb;32(1):152-161. doi: 10.1007/s12028-019-00717-4.
- Background: PubMed 32066312Achamallah N, Fried J, Love R, Matusov Y, Sharma R. Pupillary Light Reflex Is Not Abolished by Epinephrine and Atropine Given During Advanced Cardiac Life Support in Patients Who Achieve Return of Spontaneous Circulation. J Intensive Care Med. 2021 Apr;36(4):459-465. doi: 10.1177/0885066620906802. Epub 2020 Feb 18.
- Background: PubMed 30599180Lee HJ, Shin J, Hong KJ, Jung JH, Lee SJ, Jung E, You KM, Kim TH. A feasibility study for the continuous measurement of pupillary response using the pupillography during CPR in out-of-hospital cardiac arrest patients. Resuscitation. 2019 Feb;135:80-87. doi: 10.1016/j.resuscitation.2018.11.016. Epub 2018 Dec 30.
- Derived from this study: PubMed 36600432Zerbi SM, Sandroni C, Botteri M, Bellasi A, Latronico N, Rasulo F. Early Neurological ASsessment with pupillometrY during Cardiac Arrest REsuscitation (EASY-CARE): protocol for an observational multicentre prospective study. BMJ Open. 2022 Dec 20;12(12):e063633. doi: 10.1136/bmjopen-2022-063633.
- 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.
Frank A. Rasulo, Prof. contact
Simone M Zerbi, MD principal investigator
ASST Lariana Ospedale Sant'Anna di Como
Frank A Rasulo, Prof. study director
Division of Anesthesiology, Intensive Care & emergency Medicine, Università degli studi di Brescia
Marco Botteri, MD study chair
AREU - Agenzia Regionale Emergenza Urgenza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest and Out-Of-Hospital Cardiac Arrest, run by Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva at 1 site in Italy.
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 6 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 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simone M Zerbi, MD (003903155859742, smzerbi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return of spontaneous circulation (ROSC) prediction (time frame: Variable because depends on the cardiac resuscitation manoeuvers lasting usually not more than 45 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05192772, which also lists 5 linked publications.
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 26 Oct 2022.