Cardiac Arrest, Sudden Cardiac Death
Conditions
Keywords
cardiopulmonary resuscitation
Brief summary
More than 300,000 Americans experience out-of-hospital cardiac arrest annually, with overall survival rates averaging less than 5%. Low survival rates persist, in part, because manual chest compressions and ventilation, termed standard cardiopulmonary resuscitation (S-CPR), is an inherently inefficient process, providing less than 25% of normal blood flow to the heart and the brain. Hemodynamics are often compromised further by poor S-CPR techniques, especially inadequate chest compression and incomplete chest recoil. Active Compression Decompression CPR (ACD-CPR) is performed with a hand-held device that is attached to the patient's chest, and also includes a handle containing a metronome and force gauge to guide proper compression rate, depth and complete chest wall recoil. The impedance threshold device (ITD) is designed for rapid connection to an airway adjunct (e.g. facemask or endotracheal tube) and allows for positive pressure ventilation, while also impeding passive inspiratory gas exchange during chest wall decompression. Prior studies have shown that the combination of ACD-CPR + ITD enhances refilling of the heart after each compression by augmenting negative intrathoracic pressure during the decompression phase of CPR, resulting in improved cardiac and cerebral perfusion. The intrathoracic pressure regulator (ITPR) is a next generation inspiratory impedance therapy. The ITPR uses a regulated external vacuum source to lower the negative intrathoracic pressure and is therefore less dependent on the quality of CPR (e.g., completeness of chest wall recoil). The ITPR generates a pre-set continuous and controlled expiratory phase negative intrathoracic pressure that is interrupted only when positive pressure ventilation is needed to maintain oxygenation and provide gas exchange. The purpose of the study is to compare the early safety and hemodynamic effects of S-CPR, ACD- CPR + ITD, and S-CPR + ITPR in patients with out-of-hospital cardiac arrest.
Interventions
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Advanced Circulatory Systems
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Initial Inclusion Criteria: * Subject is initially presumed or known to be 18 years of age or older; * Subject presents with presumed non-traumatic, out-of-hospital cardiac arrest AND is a candidate for resuscitation attempt. \[NOTE: the cardiac arrest may be witnessed OR unwitnessed\]; * Subject has a secured cuffed advanced airway \[e.g., endotracheal tube, Combitube, King airway\]. Final Inclusion Criteria: * Subject in whom femoral arterial access was successfully established; * Subject remained in cardiac arrest (undergoing CPR) at the time of hemodynamic data acquisition; * Subject in whom at least 5 minutes of continuous hemodynamic data were able to be collected, OR if ROSC occurs before 5 minutes, at least 2 minutes of hemodynamic data were able to be collected. Initial
Exclusion criteria
* Subject has known pre-existing DNR orders in place prior to this cardiac arrest; * Subject has signs of obvious clinical death or conditions that preclude the use of CPR; * Subject's family or legal guardians request that the subject not be entered in the study at the time of arrest; * Subject has recent sternotomy, with wound not appearing completely healed (if date of sternotomy is unknown) or less than six months (if date of sternotomy is known); * Subject has a stoma, tracheotomy, or tracheostomy prior to arrest; * Subject is known or suspected to be pregnant; * Subject is known/suspected to be a prisoner. Final
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Systolic and Diastolic Blood Pressures | during CPR (day 1) | — |
| Serious Adverse Events | during the index CPR procedure (day 1), at hospital discharge, at 30 days, at three months, and at six months of follow-up | Serious adverse events include: death, internal thoracic and abdominal injuries, device malfunction preventing use during CPR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Intrathoracic Pressure (Airway Pressure) | during CPR (day 1) | Intrathoracic pressures are reported relative to atmospheric pressure |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ACD-CPR +ITD ACD-CPR+ITD: includes combined treatment with the ResQPRO active compression decompression device and the ResQPOD ITD 16.0 impedance threshold device | 18 |
| S-CPR + ITPR S-CPR + ITPR: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR) | 16 |
| S-CPR S-CPR: standard manual CPR | 14 |
| Total | 48 |
Baseline characteristics
| Characteristic | ACD-CPR +ITD | S-CPR + ITPR | S-CPR | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 11 Participants | 7 Participants | 26 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 5 Participants | 7 Participants | 22 Participants |
| Age, Continuous | 63.1 years STANDARD_DEVIATION 14.6 | 66.8 years STANDARD_DEVIATION 18.9 | 64.7 years STANDARD_DEVIATION 14 | 64.8 years STANDARD_DEVIATION 15.8 |
| Region of Enrollment United States | 18 participants | 16 participants | 14 participants | 48 participants |
| Sex: Female, Male Female | 10 Participants | 7 Participants | 5 Participants | 22 Participants |
| Sex: Female, Male Male | 8 Participants | 9 Participants | 9 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 18 | 0 / 16 | 1 / 14 |
| serious Total, serious adverse events | 10 / 18 | 8 / 16 | 6 / 14 |
Outcome results
Primary
Mean Systolic and Diastolic Blood Pressures
Time frame: during CPR (day 1)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ACD-CPR +ITD | Mean Systolic and Diastolic Blood Pressures | Systolic | 80.38 mmHg | Standard Deviation 20.71 |
| ACD-CPR +ITD | Mean Systolic and Diastolic Blood Pressures | Diastolic | 15.52 mmHg | Standard Deviation 14.1 |
| S-CPR + ITPR | Mean Systolic and Diastolic Blood Pressures | Systolic | 121.21 mmHg | Standard Deviation 22.13 |
| S-CPR + ITPR | Mean Systolic and Diastolic Blood Pressures | Diastolic | 33.04 mmHg | Standard Deviation 24.69 |
| S-CPR | Mean Systolic and Diastolic Blood Pressures | Diastolic | 19.29 mmHg | Standard Deviation 17.31 |
| S-CPR | Mean Systolic and Diastolic Blood Pressures | Systolic | 61.37 mmHg | Standard Deviation 26.23 |
Primary
Serious Adverse Events
Serious adverse events include: death, internal thoracic and abdominal injuries, device malfunction preventing use during CPR
Time frame: during the index CPR procedure (day 1), at hospital discharge, at 30 days, at three months, and at six months of follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACD-CPR +ITD | Serious Adverse Events | 11 events |
| S-CPR + ITPR | Serious Adverse Events | 9 events |
| S-CPR | Serious Adverse Events | 8 events |
Secondary
Mean Intrathoracic Pressure (Airway Pressure)
Intrathoracic pressures are reported relative to atmospheric pressure
Time frame: during CPR (day 1)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ACD-CPR +ITD | Mean Intrathoracic Pressure (Airway Pressure) | -1.05 mmHg | Standard Deviation 2.4 |
| S-CPR + ITPR | Mean Intrathoracic Pressure (Airway Pressure) | -4.40 mmHg | Standard Deviation 3.25 |
| S-CPR | Mean Intrathoracic Pressure (Airway Pressure) | 1.21 mmHg | Standard Deviation 2.57 |