Augmented Multimodal Neurologic Monitoring in High Risk Survivors of Cardiac Arrest

Cardiac arrest is the most common cause of death in the United States and as many as 590,000 Americans suffering a cardiac arrest each year. Despite advances in care, as many as 50 to 89% of patients who are resuscitated after a cardiac arrest die in the hospital. Brain injury is the most common cause of death and disability after cardiac arrest. The investigators use advanced brain monitoring in patients who are at high risk of death after cardiac arrest, with the goal of preventing ongoing brain injury. The most common problem the investigators have observed is low oxygen levels in the brain, which is often very difficult to treat.

In this study, the investigators plan to use two additional brain monitors in the care of these high risk patients: a monitor for seizures and a monitor of the amount of blood flow in the brain. The investigators will use these to detect and treat potential causes of low brain oxygen levels. The main hypotheses are that electrical events in the brain such as seizures and "spreading depolarizations" will occur during times of low brain tissue oxygen level, and that treating these events and low blood flow will reduce the rate of low brain oxygen levels.

Study Overview

• Status: Terminated
• Conditions: Cardiac Arrest
• Intervention / Treatment: Device: QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA); Device: Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI)

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• High risk survivors of cardiac arrest
• Decision by potential subject's clinical team to use our institutional standard invasive, multimodal neurologic monitoring for post-arrest care

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardiac arrest; Survivors of cardiac arrest at high risk of neurological deterioration. Participants will undergo placement of a Spencer Probe Depth Electrode and QFlow 500™ Perfusion Probe in addition to the institutional standard multimodal neurological monitoring.	Device: QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA); Device: Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spreading Depolarizations		Participants will be followed for the duration of invasive monitoring, an expected average of 5 days
Occult Seizures	Seizures detected by intracortical EEG but not surface EEG	Participants will be followed for the duration of invasive monitoring, an expected average of 5 days
Cerebral Hypoperfusion		Participants will be followed for the duration of invasive monitoring, an expected average of 5 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinically Significant Bleeding	Participants will be followed for the duration of the initial hospitalization, an expected average of 2 weeks
Monitor-associated Infection	Participants will be followed for the duration of the initial hospitalization, an expected average of 2 weeks
Device Malfunction	Participants will be followed for the duration of invasive monitoring, an expected average of 5 days

Collaborators and Investigators

• Sponsor: Jonathan Elmer
• Collaborators: Laerdal Foundation

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): October 19, 2018
• Study Completion (Actual): October 19, 2018

Study Registration Dates

• First Submitted: February 17, 2014
• First Submitted That Met QC Criteria: February 19, 2014
• First Posted (Estimate): February 24, 2014

Study Record Updates

• Last Update Posted (Actual): October 8, 2019
• Last Update Submitted That Met QC Criteria: September 17, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Cardiac arrest; Seizures; Cerebral hypoperfusion; Neurological injury; Spreading depolarizations; Brain tissue hypoxia
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: PRO13060260