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Augmented Multimodal Neurologic Monitoring in High Risk Survivors of Cardiac Arrest

Primary Purpose

Cardiac Arrest

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA)

Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI)

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring Cardiac arrest, Neurological injury, Seizures, Spreading depolarizations, Cerebral hypoperfusion, Brain tissue hypoxia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Pittsburgh

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cardiac arrest

Arm Description

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.

Outcomes

Primary Outcome Measures

Spreading Depolarizations

Occult Seizures

Seizures detected by intracortical EEG but not surface EEG

Cerebral Hypoperfusion

Secondary Outcome Measures

Clinically Significant Bleeding

Monitor-associated Infection

Device Malfunction

Full Information

NCT ID

NCT02069353

First Posted

February 17, 2014

Last Updated

September 17, 2019

Sponsor

Jonathan Elmer

Collaborators

Laerdal Foundation

1. Study Identification

Unique Protocol Identification Number

NCT02069353

Brief Title

Augmented Multimodal Neurologic Monitoring in High Risk Survivors of Cardiac Arrest

Official Title

Augmented Multimodal Neurologic Monitoring in High Risk Survivors of Cardiac Arrest

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Terminated

Why Stopped

Low enrollment

Study Start Date

July 2015 (undefined)

Primary Completion Date

October 19, 2018 (Actual)

Study Completion Date

October 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jonathan Elmer

Collaborators

Laerdal Foundation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiac Arrest

Keywords

Cardiac arrest, Neurological injury, Seizures, Spreading depolarizations, Cerebral hypoperfusion, Brain tissue hypoxia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cardiac arrest

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA)

Intervention Type

Device

Intervention Name(s)

Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI)

Primary Outcome Measure Information:

Title

Spreading Depolarizations

Time Frame

Participants will be followed for the duration of invasive monitoring, an expected average of 5 days

Title

Occult Seizures

Description

Seizures detected by intracortical EEG but not surface EEG

Time Frame

Participants will be followed for the duration of invasive monitoring, an expected average of 5 days

Title

Cerebral Hypoperfusion

Time Frame

Participants will be followed for the duration of invasive monitoring, an expected average of 5 days

Secondary Outcome Measure Information:

Title

Clinically Significant Bleeding

Time Frame

Participants will be followed for the duration of the initial hospitalization, an expected average of 2 weeks

Title

Monitor-associated Infection

Time Frame

Participants will be followed for the duration of the initial hospitalization, an expected average of 2 weeks

Title

Device Malfunction

Time Frame

Participants will be followed for the duration of invasive monitoring, an expected average of 5 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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: None

Facility Information:

Facility Name

University of Pittsburgh

City

Pittsburgh

State/Province

Pennsylvania

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Augmented Multimodal Neurologic Monitoring in High Risk Survivors of Cardiac Arrest

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