Non Invasive Neuromonitoring After Cardiac Arrest

Completed

Conditions studied: Cardiac Arrest

In brief

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.

Key facts

Study ID

NCT02575196

Run by

Icahn School of Medicine at Mount Sinai

People needed

21

Starts

2015-10-01

Expected to finish

2016-03-21

Last updated by the study team

2017-04-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Mount Sinai Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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