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Augmented Multimodal Neurologic Monitoring in High Risk Survivors of Cardiac Arrest

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ClinicalTrials.gov Identifier: NCT02069353
Recruitment Status : Recruiting
First Posted : February 24, 2014
Last Update Posted : November 14, 2017
Sponsor:
Collaborator:
Laerdal Foundation
Information provided by (Responsible Party):
Jonathan Elmer, University of Pittsburgh

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Cardiac Arrest Device: QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA) Device: Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Augmented Multimodal Neurologic Monitoring in High Risk Survivors of Cardiac Arrest
Study Start Date : July 2015
Estimated Primary Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

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)



Primary Outcome Measures :
  1. Spreading depolarizations [ Time Frame: Participants will be followed for the duration of invasive monitoring, an expected average of 5 days ]
  2. Occult seizures [ Time Frame: Participants will be followed for the duration of invasive monitoring, an expected average of 5 days ]
    Seizures detected by intracortical EEG but not surface EEG

  3. Cerebral hypoperfusion [ Time Frame: Participants will be followed for the duration of invasive monitoring, an expected average of 5 days ]

Secondary Outcome Measures :
  1. Clinically significant bleeding [ Time Frame: Participants will be followed for the duration of the initial hospitalization, an expected average of 2 weeks ]
  2. Monitor-associated infection [ Time Frame: Participants will be followed for the duration of the initial hospitalization, an expected average of 2 weeks ]
  3. Device malfunction [ Time Frame: Participants will be followed for the duration of invasive monitoring, an expected average of 5 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02069353


Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States
Contact: Beth Wesoloski    412-647-0517      
Sponsors and Collaborators
Jonathan Elmer
Laerdal Foundation

Responsible Party: Jonathan Elmer, Assistant Professor, Department of Emergency Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02069353     History of Changes
Other Study ID Numbers: PRO13060260
First Posted: February 24, 2014    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017

Keywords provided by Jonathan Elmer, University of Pittsburgh:
Cardiac arrest
Neurological injury
Seizures
Spreading depolarizations
Cerebral hypoperfusion
Brain tissue hypoxia

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases