ResQ Trial: Impact of an ITD and Active Compression Decompression CPR on Survival From Out-of-Hospital Cardiac Arrest

Study Overview
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Brief Summary
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The purpose of this study is to determine whether performing active compression decompression cardiopulmonary resuscitation (ACD-CPR) with an impedance threshold device (ITD) compared to conventional standard cardiopulmonary resuscitation (S-CPR) will impact the neurologic recovery and survival to hospital discharge following out-of-hospital cardiac arrest.

Detailed Description
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Despite receiving conventional, standard CPR (S-CPR), most patients who experience out-of-hospital cardiac arrest die prior to arriving at a hospital. At the present time, the hospital discharge rate following out-of-hospital, nontraumatic cardiac arrest in adults in the United States is estimated to be less than 5%. Many factors contribute to the current poor survival statistics, including the inefficiency of the technique itself. CPR provides only 10% to 20% of normal myocardial perfusion, and only 20% to 30% of physiologically normal cerebral perfusion. A new method of CPR that combines ACD and an ITD (ACD-CPR+ITD) has been shown in animal models and in clinical trials conducted in Europe to provide significantly more blood flow to the vital organs and to improve survival rates when compared to S-CPR or ACD-CPR alone. ACD-CPR+ITD works by decreasing intrathoracic pressure during the chest wall recoil (or decompression) phase of CPR, creating a vacuum within the thorax relative to the rest of the body. When compared with controls, use of ACD-CPR+ITD (a) enhances blood return to the thorax during the chest wall recoil phase, (b) enhances blood flow to the heart and brain, (c) provides real-time feedback to rescuers to maintain high-quality CPR, (d) improves overall CPR efficiency and, as a result of the forgoing, (e) improves short-term survival rates. The sponsor and others recently evaluated the effectiveness of the combination of conventional, manual standard CPR±ITD in animals and humans. The ITD increased short-term survival rates in these studies as well. Two clinical trials were performed in Milwaukee, Wisconsin, under IDE (#G980125). Both compared S-CPR with either a sham (nonfunctional or placebo) or active (functional) ITD. The results from the hemodynamic study demonstrated that systolic blood pressure, the primary end point, increased from approximately 45 mmHg with the sham ITD to approximately 85 mmHg with the active ITD (P less than 0.05). Intensive care unit admission rate was the primary end point of the clinical outcome study. Comparisons: The objective of this two-arm, multisite, randomized, pivotal IDE clinical trial is to compare survival to hospital discharge with neurologic recovery rates in subjects receiving S-CPR compared to ACD-CPR+ITD following out-of-hospital cardiac arrest in well-established American emergency medical services systems.

Official Title
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ResQ Trial: Comparison of Standard CPR Alone Versus Active Compression Decompression CPR Plus an ITD on Survival From Out-of-Hospital Cardiac Arrest

Conditions
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Heart Arrest, Death, Sudden, Cardiac, Cardiopulmonary Resuscitation, Cardiac Arrest

Intervention / Treatment
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* Device: Use of an impedance threshold device (ITD) during the performance of active compression decompression CPR (ACD-CPR)
* Procedure: Standard cardiopulmonary resuscitation (S-CPR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult subjects initially presumed or known to be 18 years of age or older Subjects who present with out-of-hospital cardiac arrest from presumed cardiac etiology and who receive CPR by Emergency Medical Services (EMS) personnel for at least 1 minute Subjects whose airways are managed with a cuffed ET tube, combitube, or laryngeal mask airway or facemask Exclusion Criteria: Adult subjects presumed or known to be less than 18 years of age Subjects with known or likely traumatic injuries causing cardiac arrest or cardiac arrest of presumed noncardiac origin Subjects with preexisting Do Not Resuscitate (DNR) orders Subjects with signs of obvious clinical death or conditions that preclude the use of CPR Family or legal representative request that the subject not be entered into the study Subjects experiencing in-hospital cardiac arrest Subjects with a recent sternotomy with wound not appearing completely healed (if unknown) or less than 6 months (if known) Subjects who received less than 1 minute of CPR by EMS personnel Subjects with a complete airway obstruction that cannot be cleared or in whom attempts at advanced airway management are unsuccessful Subjects intubated with a leaky or uncuffed advanced airway device or presence of stomas, tracheotomies, or tracheostomies Subjects who rearrest and are encountered by EMS within 365 days of the index cardiac arrest

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Active compression decompression cardiopulmonary resuscitation (ACD-CPR) with an impedance threshold device (ITD) | Device: Use of an impedance threshold device (ITD) during the performance of active compression decompression CPR (ACD-CPR)<br>* The ITD selectively prevents the influx of unnecessary respiratory gases into the patient during the chest wall recoil phase of CPR. The ResQPump, a hand-held device containing a suction cup, attaches to the chest and actively compresses and actively re-expands the chest during the performance of CPR.<br>* Other names: Device used to perform ACD-CPR: ResQPump;|
| Active Comparator: 2<br>Conventional standard cardiopulmonary resuscitation (S-CPR) | Procedure: Standard cardiopulmonary resuscitation (S-CPR)<br>* Conventional standard cardiopulmonary resuscitation (S-CPR)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Who Survived to Hospital Discharge With Favorable Neurologic Function Defined as MRS Score <=3 | favorable neurologic function is defined as modified Rankin Scale (MRS) score <= 3. Modified Rankin Scale measures functional outcome in stroke. It is a scale of 0-5 where 0=no symptoms at all and 5=severe disability: bedridden, incontinent, and requiring constant nursing care and attention. | When the subject is discharged from the hospital; an average of 12 days after cardiac arrest for subjects surviving to hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Event Rate as Measured by Number of Patients With One or More Adverse Events | Number of patients with one or more major adverse events, through hospital discharge. Major adverse events included: death, rearrest, pulmonary edema, seizure, bleeding requiring intervention, rib/sterna fracture, pneumothorax, hemothorax, cardiac tamponade, cerebral bleeding, aspiration, internal organ injury. | Time from cardiac arrest through hospital discharge (an average of 12 days for subjects surviving to hospital discharge | 
| Return of Spontaneous Circulation (ROSC) | Number of subjects who had ROSC, defined as any return of spontaneous circulation for any duration, reported during resuscitation in the field by EMS. | Time of cardiac arrest until discontinuation of efforts | 
| Survival to Hospital (e.g., Intensive Care Unit) Admission | Number of patients who survived to hospital or ICU admission after being transported to the emergency department (ED) after out-of-hospital cardiac arrest. | Time of hospital admission, up to 1 day after cardiac arrest | 
| Survival to 24 Hours | Number of patients who were alive 24 hours after the initial cardiac arrest. | 24 hours following cardiac arrest | 
| Survival to Hospital Discharge |  | cardiac arrest to hospital discharge | 
| Survival to 90 Days | Number of patients who are known to be alive 90 days after the index cardiac arrest. | 90 days following cardiac arrest | 
| Survival to 365 Days | Number of patients who are alive 365 days after the index cardiac arrest. | 365 days following cardiac arrest | 
| Neurological Recovery at 1 Year [Measured by Cognitive Abilities Screening Instrument (CASI)] | CASI is scored on a scale of 0-100 with 100 being the best score. The instrument evaluates attention, concentration, and short- and long-term memory as well as language and abstraction. The CASI score is a total score and not an aggregate of subscores. | One year after index arrest | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Arrest, Cardiac Arrest, Cardiopulmonary Resuscitation, Impedance Threshold Device, Active Compression Decompression, ResQPOD, ResQPump, Survival, Out-of-hospital, Prehospital, ResQCPR System