Cardiac ArrestNINCANCT02575196
Non Invasive Neuromonitoring After Cardiac Arrest
An observational study of Cardiac Arrest, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Cardiac Arrest is among the leading causes of death, with survival still well under 50% and the majority of the survivors suffering from moderate to severe neurologic deficits. The human, social and economic costs are staggering. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Non-invasive cerebral flow monitoring
- Type of treatment
- Medical device
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 21 Mar 2016
- 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: Comatose survivors of cardiac arrest
Who may be able to join
- Age ≥18 years
- Sustained ROSC within 60 minutes of arrest
- Patient is comatose (unresponsive and unable to follow verbal commands) after resuscitation
Who cannot join
- Partially or fully dependant functional status prior to index cardiac event
- Acute traumatic brain injury, SAH, massive stroke or intracranial hemorrhage
- Initiation of monitoring is not feasible for logistical reasons
- Urgent surgery planned
- Severe co-morbidity or terminal illness which makes survival to 3 months unlikely
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Prospective, Observational, Pilot Study of Noninvasive Monitoring of Regional Cerebral Blood Flow for the Evaluation of Brain Tissue Perfusion During and After Resuscitation for Cardiac Arrest
Cardiac Arrest is among the leading causes of death, with survival still well under 50% and the majority of the survivors suffering from moderate to severe neurologic deficits. The human, social and economic costs are staggering.
During resuscitation, damage is mitigated if chest compressions and other medical care are optimal, allowing some blood to reach the brain and some oxygen to reach the cells. Once the heart starts beating again, which is called return of spontaneous circulation, brain perfusion is reestablished, but usually not to normal. The now damaged brain is very fragile, can be sensitive to any changes in blood pressure or metabolic abnormalities, and swelling might set in. Hypoperfusion can persist, without the clinician's knowledge. All of these events further damage the brain and diminish the odds that the patient will regain a normal life. Therefore, the hours following return to spontaneous circulation are critical to the patient's future recovery, and constitute a window of opportunity to maximize the brain ability to heal.
Read more
In order to optimize resuscitative efforts and post-arrest management, clinicians must know what is actually happening with the most vital organ, the brain. The problem is that it is very difficult to do in a comatose patient. The available technologies only reveal indirect evidence of brain suffering, like the swelling on CT-scans, but not to continuously evaluate at the bedside if the brain actually receives enough blood.
The FDA recently approved a device named the c-flow, made by ORNIM. This device looks at red blood cells in the brain and the speed at which they move to evaluate an index of cerebral perfusion. It does so with sensors put on the patient's forehead, which emit and detect ultrasounds and infrared light. This index can inform the clinician about the amount of blood flow the brain receives, and it can be put in place very quickly, even during resuscitative efforts, and without any danger for the patient.
The study looks at how well the information obtained with the c-flow matches the one obtained from other indirect indices and, more importantly, how well it predicts patient outcome. The investigators wish to establish threshold values of this index of perfusion that predict a good recovery so that this information may be used to optimize patient's neurological outcome in the near future.
Read the detailed description
Primary Objective:
Cardio-Pulmonary Resuscitation (CPR) is undergoing a major paradigm shift, with new emphasis on optimizing neurological recovery. As a result, Cardio-Cerebral Resuscitation (CCR) is now the preferred term for describing protocols directed at promoting survival and recovery from cardiac arrest. Establishing and maintaining brain perfusion is the critical endpoint of resuscitation; however, there is currently no simple and reliable way to evaluate the adequacy of brain tissue perfusion in cardiac arrest patients. The overall goal of the NINCA study is to determine if non-invasive cerebral blood flow index (CFI) can be used as a simple and effective measurement of brain perfusion during and after resuscitation from cardiac arrest. Our researchers hypothesize that this monitoring may one day be routinely used to (1) evaluate the adequacy of chest compressions, (2) avoid brain tissue hypoperfusion induced by excessive hyperventilation or shivering, (3) serve as an endpoint for goal-directed hemodynamic support, (4) evaluate the potential for neurological recovery, and (5) help guide post-cardiac arrest care.
Implications for Further Research:
Successful completion of the research will hopefully establish that non- invasive cerebral blood flow monitoring is feasible during and after CPR; is dependent on adequate MAP, CO, temperature, SpO2 and ventilation; and is a valid predictor of neurological recovery. If confirmed, such monitors may one day become part of standard ICU post-cardiac arrest monitoring and even be part of standard resuscitation equipment.
Determination of optimal CFI thresholds or targets will support future studies to determine if "goal directed" and individualized post-resuscitation ICU care is feasible using non-invasive cerebral perfusion indices. This could lead to a new way of optimizing hemodynamic support, temperature management and ventilation strategies to maintain adequate cerebral perfusion and improve neurological outcomes.
- Conditions
- Cardiac Arrest
- Being tested
- Non-invasive cerebral flow monitoring
- Keywords
- Cardiac arrest, Cardiopulmonary Resuscitation, CPR, cerebral blood flow, cerebral perfusion
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive cerebral flow monitoringDevice
Also called c-flow monitor (ORNIM)
As soon as possible after ROSC, c-flow monitor will be connected to the patient, recording cerebral flow index for the first 72 hours following ROSC. All other relevant clinical data will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac arrest | Consecutive adult cardiac arrest patients with sustained ROSC in an academic medical center Receives: Device: Non-invasive cerebral flow monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral Performance Category
Neurological Outcome by good functional recovery
Measured: 7 days
Modified Rankin Scale
Neurological Outcome
Measured: 7 days
Secondary outcomes (1)
Survival Rate
Survival with good functional recovery
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study startOct 2015
- Primary completion21 Mar 2016
- Study completion21 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephan A Mayer, MD, Principal investigator, Neurology Department, Mount Sinai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02575196
- Sponsor's protocol ID
- GCO 15-1105
- Acronym
- NINCA
- Status last verified
- Apr 2017
- First submitted
- 12 Oct 2015
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Francoeur CL, Lee J, Dangayach N, Gidwani U, Mayer SA. Non-invasive cerebral perfusion monitoring in cardiac arrest patients: a prospective cohort study. Clin Neurol Neurosurg. 2020 Sep;196:105970. doi: 10.1016/j.clineuro.2020.105970. Epub 2020 May 30.
PubMed 32505869
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Prospective, Observational, Pilot Study of Noninvasive Monitoring of Regional Cerebral Blood Flow for the Evaluation of Brain Tissue Perfusion During and After Resuscitation for Cardiac Arrest
- ClinicalTrials.gov ID
- NCT02575196
- Acronym / sponsor ID
- NINCA / GCO 15-1105
- Conditions
- Cardiac Arrest
- Keywords
- Cardiac arrest, Cardiopulmonary Resuscitation, CPR, cerebral blood flow, cerebral perfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- 21 Mar 2016 (actual)
- Study completion
- 21 Mar 2016 (actual)
- First posted
- 14 Oct 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.
Cardiac Arrest is among the leading causes of death, with survival still well under 50% and the majority of the survivors suffering from moderate to severe neurologic deficits. The human, social and economic costs are staggering.
During resuscitation, damage is mitigated if chest compressions and other medical care are optimal, allowing some blood to reach the brain and some oxygen to reach the cells. Once the heart starts beating again, which is called return of spontaneous circulation, brain perfusion is reestablished, but usually not to normal. The now damaged brain is very fragile, can be sensitive to any changes in blood pressure or metabolic abnormalities, and swelling might set in. Hypoperfusion can persist, without the clinician's knowledge. All of these events further damage the brain and diminish the odds that the patient will regain a normal life. Therefore, the hours following return to spontaneous circulation are critical to the patient's future recovery, and constitute a window of opportunity to maximize the brain ability to heal.
In order to optimize resuscitative efforts and post-arrest management, clinicians must know what is actually happening with the most vital organ, the brain. The problem is that it is very difficult to do in a comatose patient. The available technologies only reveal indirect evidence of brain suffering, like the swelling on CT-scans, but not to continuously evaluate at the bedside if the brain actually receives enough blood.
The FDA recently approved a device named the c-flow, made by ORNIM. This device looks at red blood cells in the brain and the speed at which they move to evaluate an index of cerebral perfusion. It does so with sensors put on the patient's forehead, which emit and detect ultrasounds and infrared light. This index can inform the clinician about the amount of blood flow the brain receives, and it can be put in place very quickly, even during resuscitative efforts, and without any danger for the patient.
The study looks at how well the information obtained with the c-flow matches the one obtained from other indirect indices and, more importantly, how well it predicts patient outcome. The investigators wish to establish threshold values of this index of perfusion that predict a good recovery so that this information may be used to optimize patient's neurological outcome in the near future.
Detailed description
Primary Objective:
Cardio-Pulmonary Resuscitation (CPR) is undergoing a major paradigm shift, with new emphasis on optimizing neurological recovery. As a result, Cardio-Cerebral Resuscitation (CCR) is now the preferred term for describing protocols directed at promoting survival and recovery from cardiac arrest. Establishing and maintaining brain perfusion is the critical endpoint of resuscitation; however, there is currently no simple and reliable way to evaluate the adequacy of brain tissue perfusion in cardiac arrest patients. The overall goal of the NINCA study is to determine if non-invasive cerebral blood flow index (CFI) can be used as a simple and effective measurement of brain perfusion during and after resuscitation from cardiac arrest. Our researchers hypothesize that this monitoring may one day be routinely used to (1) evaluate the adequacy of chest compressions, (2) avoid brain tissue hypoperfusion induced by excessive hyperventilation or shivering, (3) serve as an endpoint for goal-directed hemodynamic support, (4) evaluate the potential for neurological recovery, and (5) help guide post-cardiac arrest care.
Implications for Further Research:
Successful completion of the research will hopefully establish that non- invasive cerebral blood flow monitoring is feasible during and after CPR; is dependent on adequate MAP, CO, temperature, SpO2 and ventilation; and is a valid predictor of neurological recovery. If confirmed, such monitors may one day become part of standard ICU post-cardiac arrest monitoring and even be part of standard resuscitation equipment.
Determination of optimal CFI thresholds or targets will support future studies to determine if "goal directed" and individualized post-resuscitation ICU care is feasible using non-invasive cerebral perfusion indices. This could lead to a new way of optimizing hemodynamic support, temperature management and ventilation strategies to maintain adequate cerebral perfusion and improve neurological outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac arrest | – | Device: Non-invasive cerebral flow monitoringConsecutive adult cardiac arrest patients with sustained ROSC in an academic medical center |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Comatose survivors of cardiac arrest
Key inclusion criteria (3 listed)
- Age ≥18 years
- Sustained ROSC within 60 minutes of arrest
- Patient is comatose (unresponsive and unable to follow verbal commands) after resuscitation
Key exclusion criteria (6 listed)
- Partially or fully dependant functional status prior to index cardiac event
- Acute traumatic brain injury, SAH, massive stroke or intracranial hemorrhage
- Initiation of monitoring is not feasible for logistical reasons
- Urgent surgery planned
- Severe co-morbidity or terminal illness which makes survival to 3 months unlikely
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 |
|---|---|---|
| Non-invasive cerebral flow monitoringAlso: c-flow monitor (ORNIM)As soon as possible after ROSC, c-flow monitor will be connected to the patient, recording cerebral flow index for the first 72 hours following ROSC. All other relevant clinical data will be recorded. | Device | Cardiac arrest |
Primary outcome
Cerebral Performance Category
Time frame: 7 days
Neurological Outcome by good functional recovery
Modified Rankin Scale
Time frame: 7 days
Neurological Outcome
1 secondary outcome
Survival Rate
Time frame: 7 days
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 19 Apr 2017.
- Derived from this study: PubMed 32505869Francoeur CL, Lee J, Dangayach N, Gidwani U, Mayer SA. Non-invasive cerebral perfusion monitoring in cardiac arrest patients: a prospective cohort study. Clin Neurol Neurosurg. 2020 Sep;196:105970. doi: 10.1016/j.clineuro.2020.105970. Epub 2020 May 30.
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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.
Stephan A Mayer, MD principal investigator
Neurology Department, Mount Sinai Hospital
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, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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: finished, as of the sponsor's last update on 19 Apr 2017. 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 United States. 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?
Cerebral Performance Category (time frame: 7 days). The study lists 2 primary outcomes in all. 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 NCT02575196, which also lists 1 linked publication.
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 19 Apr 2017.