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Non Invasive Neuromonitoring After Cardiac Arrest (NINCA)
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.
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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New York
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New York, New York, Verenigde Staten, 10029
- Mount Sinai Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Age ≥18 years
- Sustained ROSC within 60 minutes of arrest
- Patient is comatose (unresponsive and unable to follow verbal commands) after resuscitation
Exclusion Criteria:cerebral perfusion
- 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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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Cardiac arrest
Consecutive adult cardiac arrest patients with sustained ROSC in an academic medical center
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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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Cerebral Performance Category
Tijdsspanne: 7 days
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Neurological Outcome by good functional recovery
|
7 days
|
|
Modified Rankin Scale
Tijdsspanne: 7 days
|
Neurological Outcome
|
7 days
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Survival Rate
Tijdsspanne: 7 days
|
Survival with good functional recovery
|
7 days
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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MoCA
Tijdsspanne: 7 days
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Cognitive outcome
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7 days
|
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EQ-5L-5D
Tijdsspanne: 7 days
|
quality of life outcome
|
7 days
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Stephan A Mayer, MD, Neurology Department, Mount Sinai Hospital
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- GCO 15-1105
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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