Non Invasive Neuromonitoring After Cardiac Arrest
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/20/2017 |
| Start Date: | October 2015 |
| End Date: | March 21, 2016 |
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.
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.
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
