Cardiac ArrestNCT02069353
Augmented Multimodal Neurologic Monitoring in High Risk Survivors of Cardiac Arrest
A study testing QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA) and Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI) in people with Cardiac Arrest, run by Jonathan Elmer at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA) and Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 19 Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cardiac Arrest
- Being tested
- QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA), Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI)
- Keywords
- Cardiac arrest, Neurological injury, Seizures, Spreading depolarizations, Cerebral hypoperfusion, Brain tissue hypoxia
- Medical subject headings
- Heart Arrest, Trauma, Nervous System, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA)Device
Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI)Device
| Study group | Role | What they receive |
|---|---|---|
| Cardiac arrest | Experimental | 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. Receives: Device: QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA); Device: Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spreading Depolarizations
Measured: 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
Measured: Participants will be followed for the duration of invasive monitoring, an expected average of 5 days
Cerebral Hypoperfusion
Measured: Participants will be followed for the duration of invasive monitoring, an expected average of 5 days
Secondary outcomes (3)
Clinically Significant Bleeding
Measured: Participants will be followed for the duration of the initial hospitalization, an expected average of 2 weeks
Monitor-associated Infection
Measured: Participants will be followed for the duration of the initial hospitalization, an expected average of 2 weeks
Device Malfunction
Measured: Participants will be followed for the duration of invasive monitoring, an expected average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startJul 2015
- Primary completion19 Oct 2018
- Study completion19 Oct 2018
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonathan Elmer
- Sponsor type
- University, hospital or other
- Collaborators
- Laerdal Foundation
- Responsible party
- Sponsor-investigator, Jonathan Elmer, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069353
- Sponsor's protocol ID
- PRO13060260
- Status last verified
- Sep 2019
- First submitted
- 17 Feb 2014
- Last updated
- 8 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmented Multimodal Neurologic Monitoring in High Risk Survivors of Cardiac Arrest
- ClinicalTrials.gov ID
- NCT02069353
- Acronym / sponsor ID
- PRO13060260
- Conditions
- Cardiac Arrest
- Keywords
- Cardiac arrest, Neurological injury, Seizures, Spreading depolarizations, Cerebral hypoperfusion, Brain tissue hypoxia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Jonathan ElmerUniversity, hospital or other
- Collaborators
- Laerdal Foundation
- Study start
- Jul 2015
- Primary completion
- 19 Oct 2018 (actual)
- Study completion
- 19 Oct 2018 (actual)
- First posted
- 24 Feb 2014 (estimated)
- Results
- Posted 8 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac arrest | Experimental | Device: QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA), Device: Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA) | Device | Cardiac arrest |
| Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI) | Device | Cardiac arrest |
Primary outcome
Spreading Depolarizations
Time frame: Participants will be followed for the duration of invasive monitoring, an expected average of 5 days
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
Cerebral Hypoperfusion
Time frame: Participants will be followed for the duration of invasive monitoring, an expected average of 5 days
3 secondary outcomes
Clinically Significant Bleeding
Time frame: Participants will be followed for the duration of the initial hospitalization, an expected average of 2 weeks
Monitor-associated Infection
Time frame: Participants will be followed for the duration of the initial hospitalization, an expected average of 2 weeks
Device Malfunction
Time frame: Participants will be followed for the duration of invasive monitoring, an expected average of 5 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA) and Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI) in people with Cardiac Arrest, run by Jonathan Elmer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spreading Depolarizations (time frame: Participants will be followed for the duration of invasive monitoring, an expected average of 5 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2019; AzTrials last refreshed its copy on 8 Nov 2026.