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

Advanced Circulatory Systems1,653 enrolled

Overview

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.

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.

Interventions

Use of an impedance threshold device (ITD) during the performance of active compression decompression CPR (ACD-CPR)DEVICE

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.

Standard cardiopulmonary resuscitation (S-CPR)PROCEDURE

Conventional standard cardiopulmonary resuscitation (S-CPR)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Site 07: Indianapolis, IN

Indianapolis, Indiana, United States

Site 06: Washtenaw & Livingston Counties, MI

Ann Arbor, Michigan, United States

Site 04: Oakland & Macomb Counties, MI

Royal Oak, Michigan, United States

Site 02: Minneapolis, MN

Minneapolis, Minnesota, United States

Site 01: St. Paul, MN

Saint Paul, Minnesota, United States

Site 03: Whatcom County, WA

Bellingham, Washington, United States

Site 05: Oshkosh, WI

Oshkosh, Wisconsin, United States

Outcomes

Primary Outcomes

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.

Time frame: When the subject is discharged from the hospital; an average of 12 days after cardiac arrest for subjects surviving to hospital discharge

Secondary Outcomes

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 frame: 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 frame: 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 frame: 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.

Time frame: 24 hours following cardiac arrest

Survival to Hospital Discharge

Time frame: 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.

Time frame: 90 days following cardiac arrest

Survival to 365 Days

Number of patients who are alive 365 days after the index cardiac arrest.

Time frame: 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.

Time frame: One year after index arrest