Augmented Multimodal Neurologic Monitoring in High Risk Survivors of Cardiac Arrest

• Sponsor: Jonathan Elmer (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02069353
• Collaborator: Laerdal Foundation (Other)
• Enrollment: 4
• Location: 1
• Arm: 1
• Duration (Months): 39.6
• Patients Per Site Per Month: 0.1

Study Details

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.

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)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: N/A
• 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: Jul 1, 2015
• Actual Primary Completion Date: Oct 19, 2018
• Actual Study Completion Date: Oct 19, 2018

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Spreading Depolarizations [Participants will be followed for the duration of invasive monitoring, an expected average of 5 days]

2. Occult Seizures [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 [Participants will be followed for the duration of invasive monitoring, an expected average of 5 days]

Secondary Outcome Measures

1. Clinically Significant Bleeding [Participants will be followed for the duration of the initial hospitalization, an expected average of 2 weeks]

2. Monitor-associated Infection [Participants will be followed for the duration of the initial hospitalization, an expected average of 2 weeks]

3. Device Malfunction [Participants will be followed for the duration of invasive monitoring, an expected average of 5 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh	Pittsburgh	Pennsylvania	United States

Sponsors and Collaborators

• Jonathan Elmer
• Laerdal Foundation

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 30, 2018

More Information

Publications

None provided.

• Responsible Party: Jonathan Elmer, Assistant Professor, Department of Emergency Medicine, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT02069353
• Other Study ID Numbers: PRO13060260
• First Posted: Feb 24, 2014
• Last Update Posted: Oct 8, 2019
• Last Verified: Sep 1, 2019

• Keywords provided by Jonathan Elmer, Assistant Professor, Department of Emergency Medicine, University of Pittsburgh: Cardiac arrest; Neurological injury; Seizures; Spreading depolarizations; Cerebral hypoperfusion; Brain tissue hypoxia
• Additional relevant MeSH terms: Heart Arrest

Study Results

Participant Flow

Arm/Group Title	Cardiac Arrest
Arm/Group 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. QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA) Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI)
Period Title: Overall Study
STARTED	4
COMPLETED	4
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Cardiac Arrest
Arm/Group 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. QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA) Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI)
Overall Participants	4
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	3 75%
>=65 years	1 25%
Sex: Female, Male (Count of Participants)
Female	3 75%
Male	1 25%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 25%
White	3 75%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	4 100%

Outcome Measures

1. Primary Outcome

Title	Spreading Depolarizations
Time Frame	Participants will be followed for the duration of invasive monitoring, an expected average of 5 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cardiac Arrest
Arm/Group 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. QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA) Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI)
Measure Participants	4
Count of Participants [Participants]	0 0%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cardiac Arrest
Arm/Group 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. QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA) Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI)
Measure Participants	4
Count of Participants [Participants]	0 0%

3. Primary Outcome

Title	Cerebral Hypoperfusion
Time Frame	Participants will be followed for the duration of invasive monitoring, an expected average of 5 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cardiac Arrest
Arm/Group 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. QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA) Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI)
Measure Participants	4
Count of Participants [Participants]	4 100%

4. Secondary Outcome

Title	Clinically Significant Bleeding
Time Frame	Participants will be followed for the duration of the initial hospitalization, an expected average of 2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cardiac Arrest
Arm/Group 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. QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA) Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI)
Measure Participants	4
Count of Participants [Participants]	0 0%

5. Secondary Outcome

Title	Monitor-associated Infection
Time Frame	Participants will be followed for the duration of the initial hospitalization, an expected average of 2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cardiac Arrest
Arm/Group 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. QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA) Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI)
Measure Participants	4
Count of Participants [Participants]	0 0%

6. Secondary Outcome

Title	Device Malfunction
Time Frame	Participants will be followed for the duration of invasive monitoring, an expected average of 5 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cardiac Arrest
Arm/Group 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. QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA) Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI)
Measure Participants	4
Count of Participants [Participants]	0 0%

Adverse Events

Time Frame	Duration of index hospitalization, a median of 3 days.
Adverse Event Reporting Description	Patients were examined by a study investigator daily to assess for adverse events until death or discharge.
Arm/Group Title	Cardiac Arrest
Arm/Group 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. QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA) Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI)
All Cause Mortality
	Cardiac Arrest
	Affected / at Risk (%)	# Events
Total	3/4 (75%)
Serious Adverse Events
	Cardiac Arrest
	Affected / at Risk (%)	# Events
Total	0/4 (0%)
Other (Not Including Serious) Adverse Events
	Cardiac Arrest
	Affected / at Risk (%)	# Events
Total	0/4 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.