Cardiac Arrest
Conditions
Keywords
Cardiac arrest, Neurological injury, Seizures, Spreading depolarizations, Cerebral hypoperfusion, Brain tissue hypoxia
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.
Interventions
DEVICEQFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA)
DEVICESpencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI)
Sponsors
Laerdal Foundation
Jonathan Elmer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spreading Depolarizations | Participants will be followed for the duration of invasive monitoring, an expected average of 5 days | — |
| 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 |
| Cerebral Hypoperfusion | Participants will be followed for the duration of invasive monitoring, an expected average of 5 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinically Significant Bleeding | Participants will be followed for the duration of the initial hospitalization, an expected average of 2 weeks |
| Monitor-associated Infection | Participants will be followed for the duration of the initial hospitalization, an expected average of 2 weeks |
| Device Malfunction | Participants will be followed for the duration of invasive monitoring, an expected average of 5 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA)
Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI) | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | Cardiac Arrest |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 4 |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
Cerebral Hypoperfusion
Time frame: Participants will be followed for the duration of invasive monitoring, an expected average of 5 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cardiac Arrest | Cerebral Hypoperfusion | 4 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cardiac Arrest | Occult Seizures | 0 Participants |
Primary
Spreading Depolarizations
Time frame: Participants will be followed for the duration of invasive monitoring, an expected average of 5 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cardiac Arrest | Spreading Depolarizations | 0 Participants |
Secondary
Clinically Significant Bleeding
Time frame: Participants will be followed for the duration of the initial hospitalization, an expected average of 2 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cardiac Arrest | Clinically Significant Bleeding | 0 Participants |
Secondary
Device Malfunction
Time frame: Participants will be followed for the duration of invasive monitoring, an expected average of 5 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cardiac Arrest | Device Malfunction | 0 Participants |
Secondary
Monitor-associated Infection
Time frame: Participants will be followed for the duration of the initial hospitalization, an expected average of 2 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cardiac Arrest | Monitor-associated Infection | 0 Participants |