Cardiac Arrest, Cardiopulmonary Arrest, Cardiopulmonary Resuscitation, CPR, Death, Sudden, Cardiac, Extracorporeal Cardiopulmonary Resuscitation, Extracorporeal Membrane Oxygenation, Heart Arrest, Sudden Cardiac Arrest
Conditions
Keywords
Out-of-hospital cardiac arrest, Cardiac Arrest, Heart Arrest, Sudden Cardiac Arrest, Cardiopulmonary Resuscitation, Extracorporeal Cardiopulmonary Resuscitation, Extracorporeal Membrane Oxygenation, CPR, ECPR, ECMO, Emergency Medical Services, EMS, OHCA
Brief summary
In the U.S. alone, over 300,000 people per year have sudden out-of-hospital cardiac arrest (OHCA), and less than 1 out of 10 survive. The current standard practice for treating OHCA is to perform cardiopulmonary resuscitation (CPR) and Advanced Cardiovascular Life Support (ACLS) at the scene until either the heart is restarted or resuscitation efforts are considered hopeless and discontinued. An alternative strategy for those with refractory OHCA is expedited transport with ongoing mechanical CPR to an Emergency Department capable of performing extracorporeal cardiopulmonary resuscitation (ECPR). The purpose of study is to test if this strategy is feasible and beneficial.
Detailed description
Out-of-hospital sudden cardiac arrest (OHCA) is a life-threatening condition in which the heart suddenly stops beating and there is no blood flow to the body. If cardiac arrest is not treated immediately, it causes sudden death. In the U.S. alone, over 300,000 people per year have OHCA, and less than 1 out of 10 survive. Therefore, it is important to study new ways of treating cardiac arrest patients in order to improve survival. The current standard practice for treating OHCA is to perform CPR and Advanced Cardiovascular Life Support (ACLS) at the scene until either the heart is restarted or resuscitation efforts are considered hopeless and discontinued. This practice is supported by the fact that all currently proven CPR therapies can be delivered by paramedics in the field. However, promising new strategies have emerged that are more feasible to initiate in the hospital. One such strategy is extracorporeal cardiopulmonary resuscitation (ECPR). ECPR requires placement of catheters in large blood vessels and connected to a machine to take over the work of the heart and lungs. This purpose of this study is to examine the feasibility and potential benefit of expedited transport with ongoing mechanical CPR for patients with refractory OHCA patients to an Emergency Department capable of initiating ECPR. FDA approved this study as a staged feasibility study to enroll 15 participants and submit data prior to enrolling the second 15 participants. After enrolling 15 participants, the PI chose not to pursue an amendment to enroll additional participants due to slow accrual and research restrictions related to COVID.
Interventions
DEVICEExpedited Transport With Mechanical CPR
Patients with OHCA refractory to initial BLS and ACLS will be transported by EMS with ongoing mechanical CPR and ACLS to an emergency department capable of initiating ECPR.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Food and Drug Administration (FDA)
Physio-Control
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* OHCA of presumed non-traumatic etiology requiring CPR * Predicted arrival time at ECPR-capable hospital within timeframe specified * Witnessed arrest or initial shockable rhythm (VT or VF) * Persistent cardiac arrest after initial cardiac rhythm analysis and shock (if shock is indicated)
Exclusion criteria
* Sustained return of spontaneous circulation (ROSC) * Advanced directive indicating do not attempt resuscitation (DNAR) or do not intubate (DNI) * Preexisting evidence of opting out of study * Prisoner * Pregnant (obvious or known) * ECPR capable ED is not at the destination hospital as determined by EMS * Legally authorized representative (LAR) or family member aware of study and refuses study participation at the scene
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emergency Department Arrivals Under 30 Minutes | Measured within one hour cardiac arrest onset | Proportion of patients with emergency department (ED) arrival less than or equal to 30 minutes from 911 call (or cardiac arrest onset if witnessed by EMS personnel). |
| ECPR Initiations Under 30 Minutes | Measured within 2 hours of cardiac arrest onset | Proportion of ECPR eligible patients with ECPR flow initiated less than or equal to 30 minutes from ED arrival |
Other
| Measure | Time frame | Description |
|---|---|---|
| Neuropsychological Outcome Battery: NIH Toolbox | At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest | The NIH toolbox includes cognitive testing and can be administered using an iPad |
| Functional Neurological Outcome: CPC | At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest | Cerebral Performance Category score is widely used in cardiac arrest research to assess neurologic outcome |
| Safety: Composite Prevalence of 6 Specified Adverse Events | At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest | Composite safety endpoint of hemorrhage requiring blood transfusion, vessel damage requiring vascular procedure or leading to occlusion, venous/arterial thromboembolism, stroke, renal failure, and infection. |
| Neuro Quality of Life: Neuro QoL | 90 days after cardiac arrest | Quality of Life in Neurological Disorders is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults living with neurological conditions. |
| Functional Neurological Outcome: mRS | At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest | modified Rankin Score commonly used for measuring the degree of disability or dependence in the daily activities of people who have suffered a neurological disability. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Care Basic Life Support (BLS) and Advanced Cardiovascular Life Support (ACLS) by Emergency Medical Services (EMS) per existing EMS protocols at the scene of the cardiac arrest. | 3 |
| Expedited Transport Intervention: Expedited Transport with Mechanical CPR.
After initial Basic Life Support (BLS) and Advanced Cardiovascular Life Support (ACLS) by Emergency Medical Services (EMS) per existing EMS protocols, patients with refractory cardiac arrest are transported to an ECPR capable emergency department with ongoing mechanical CPR and ACLS for possible initiation of extracorporeal cardiopulmonary resuscitation (ECPR).
Expedited Transport With Mechanical CPR: Patients with OHCA refractory to initial BLS and ACLS will be transported by EMS with ongoing mechanical CPR and ACLS to an emergency department capable of initiating ECPR. | 12 |
| Total | 15 |
Baseline characteristics
| Characteristic | Standard Care | Expedited Transport | Total |
|---|---|---|---|
| Age, Continuous | 61 years STANDARD_DEVIATION 3 | 62 years STANDARD_DEVIATION 8 | 62 years STANDARD_DEVIATION 7 |
| Bystander CPR | 3 Participants | 10 Participants | 13 Participants |
| Cardiac Arrest Locaion Home | 2 participants | 10 participants | 12 participants |
| Cardiac Arrest Locaion Public Location | 1 participants | 2 participants | 3 participants |
| Initial cardiac rythm Ventricular fibrilation | 3 Participants | 5 Participants | 8 Participants |
| Initial cardiac rythm Witnessed asystole | 0 Participants | 3 Participants | 3 Participants |
| Initial cardiac rythm Witnessed pulseless electrical activity (PEA) | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 3 Participants | 9 Participants | 12 Participants |
| Sex: Female, Male Female | 1 Participants | 4 Participants | 5 Participants |
| Sex: Female, Male Male | 2 Participants | 8 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 3 | 12 / 12 |
| other Total, other adverse events | 0 / 3 | 0 / 12 |
| serious Total, serious adverse events | 2 / 3 | 6 / 12 |
Outcome results
Primary
ECPR Initiations Under 30 Minutes
Proportion of ECPR eligible patients with ECPR flow initiated less than or equal to 30 minutes from ED arrival
Time frame: Measured within 2 hours of cardiac arrest onset
Population: Analysis includes participants eligible for ECPR.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Expedited Transport | ECPR Initiations Under 30 Minutes | 3 Participants |
Primary
Emergency Department Arrivals Under 30 Minutes
Proportion of patients with emergency department (ED) arrival less than or equal to 30 minutes from 911 call (or cardiac arrest onset if witnessed by EMS personnel).
Time frame: Measured within one hour cardiac arrest onset
Population: Standard care participants received EMS protocols at the scene, and thus were not included in this analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Expedited Transport | Emergency Department Arrivals Under 30 Minutes | 5 Participants |
Other Pre-specified
Functional Neurological Outcome: CPC
Cerebral Performance Category score is widely used in cardiac arrest research to assess neurologic outcome
Time frame: At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest
Other Pre-specified
Functional Neurological Outcome: mRS
modified Rankin Score commonly used for measuring the degree of disability or dependence in the daily activities of people who have suffered a neurological disability.
Time frame: At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest
Other Pre-specified
Neuropsychological Outcome Battery: NIH Toolbox
The NIH toolbox includes cognitive testing and can be administered using an iPad
Time frame: At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest
Other Pre-specified
Neuro Quality of Life: Neuro QoL
Quality of Life in Neurological Disorders is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults living with neurological conditions.
Time frame: 90 days after cardiac arrest
Other Pre-specified
Safety: Composite Prevalence of 6 Specified Adverse Events
Composite safety endpoint of hemorrhage requiring blood transfusion, vessel damage requiring vascular procedure or leading to occlusion, venous/arterial thromboembolism, stroke, renal failure, and infection.
Time frame: At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest