Non Invasive Neuromonitoring After Cardiac Arrest

NCT02575196 | Completed

• 1 other identifier: GCO 15-1105
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cardiac Arrest

Keywords

Cardiac arrest; Cardiopulmonary Resuscitation; CPR; cerebral blood flow; cerebral perfusion

Outcome Measures

Primary Outcomes (2)

• Cerebral Performance Category

  Neurological Outcome by good functional recovery

  7 days

• Modified Rankin Scale

  Neurological Outcome

  7 days

Secondary Outcomes (1)

• Survival Rate

  7 days

Other Outcomes (2)

• MoCA

  7 days

• EQ-5L-5D

  7 days

Study Arms (1)

Cardiac arrest

Consecutive adult cardiac arrest patients with sustained ROSC in an academic medical center

Device: Non-invasive cerebral flow monitoring

Interventions

Non-invasive cerebral flow monitoring DEVICE

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.

Also known as: c-flow monitor (ORNIM)

Cardiac arrest

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Comatose survivors of cardiac arrest

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Related Publications (1)

• 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.

  PMID: 32505869 DERIVED

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Stephan A Mayer, MD

  Neurology Department, Mount Sinai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2015
• First Posted: October 14, 2015
• Study Start: October 1, 2015
• Primary Completion: March 21, 2016
• Study Completion: March 21, 2016
• Last Updated: April 19, 2017

Record last verified: 2017-04

Locations

US (1)