An interventional study of QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA) and Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI) in Cardiac Arrest, sponsored by Jonathan Elmer. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-08.
Sponsored by Jonathan Elmer · Not applicable, Interventional, and Treatment
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.
984 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.
This study's enrollment of 4 is below the median of 100 across 563 interventional studies indexed under Heart Arrest.
Browse Heart Arrest studies →This is the only study on the registry with Jonathan Elmer as lead sponsor.
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Exclusion Criteria:
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)
Spreading Depolarizations
Time frame: 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
Time frame: Participants will be followed for the duration of invasive monitoring, an expected average of 5 days
Cerebral Hypoperfusion
Time frame: Participants will be followed for the duration of invasive monitoring, an expected average of 5 days
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
| Milestone | Cardiac Arrest |
|---|---|
| Started | 4 |
| Completed | 4 |
| Not completed | 0 |
| Participants | Cardiac Arrest |
|---|---|
| Spreading Depolarizations | 0 |
Seizures detected by intracortical EEG but not surface EEG
| Participants | Cardiac Arrest |
|---|---|
| Occult Seizures | 0 |
| Participants | Cardiac Arrest |
|---|---|
| Cerebral Hypoperfusion | 4 |
| Participants | Cardiac Arrest |
|---|---|
| Clinically Significant Bleeding | 0 |
| Participants | Cardiac Arrest |
|---|---|
| Monitor-associated Infection | 0 |
| Participants | Cardiac Arrest |
|---|---|
| Device Malfunction | 0 |
Collected over Duration of index hospitalization, a median of 3 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cardiac Arrest | 3/4 (75%) | 0/4 (0%) | 0/4 (0%) |
| Age, Categorical(Participants) | Cardiac Arrest |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 3 |
| >=65 years | 1 |
| Sex: Female, Male(Participants) | Cardiac Arrest |
|---|---|
| Female | 3 |
| Male | 1 |
| Race (NIH/OMB)(Participants) | Cardiac Arrest |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 3 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Cardiac Arrest |
|---|---|
| United States | 4 |
Documents are hosted by the registry — open the source record to download them.
The record gives a start of Jul 2015, a primary completion of Oct 2018 and a completion of Oct 2018. It does not say whether these dates are actual or estimated.
Results were first posted in Oct 2019, 11 months after primary completion.
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This study is terminated, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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