ResQ Trial: Impact of an ITD and Active Compression Decompression CPR on Survival From Out-of-Hospital Cardiac Arrest (ResQ)
|Heart Arrest Death, Sudden, Cardiac Cardiopulmonary Resuscitation Cardiac Arrest||Device: Use of an impedance threshold device (ITD) during the performance of active compression decompression CPR (ACD-CPR) Procedure: Standard cardiopulmonary resuscitation (S-CPR)|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||ResQ Trial: Comparison of Standard CPR Alone Versus Active Compression Decompression CPR Plus an ITD on Survival From Out-of-Hospital Cardiac Arrest|
- Number of Patients Who Survived to Hospital Discharge With Favorable Neurologic Function Defined as MRS Score <=3 [ Time Frame: When the subject is discharged from the hospital; an average of 12 days after cardiac arrest for subjects surviving to hospital discharge ]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.
- Major Adverse Event Rate as Measured by Number of Patients With One or More Adverse Events [ Time Frame: Time from cardiac arrest through hospital discharge (an average of 12 days for subjects surviving to hospital discharge ]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.
- Return of Spontaneous Circulation (ROSC) [ Time Frame: Time of cardiac arrest until discontinuation of efforts ]Number of subjects who had ROSC, defined as any return of spontaneous circulation for any duration, reported during resuscitation in the field by EMS.
- Survival to Hospital (e.g., Intensive Care Unit) Admission [ Time Frame: Time of hospital admission, up to 1 day after cardiac arrest ]Number of patients who survived to hospital or ICU admission after being transported to the emergency department (ED) after out-of-hospital cardiac arrest.
- Survival to 24 Hours [ Time Frame: 24 hours following cardiac arrest ]Number of patients who were alive 24 hours after the initial cardiac arrest.
- Survival to Hospital Discharge [ Time Frame: cardiac arrest to hospital discharge ]
- Survival to 90 Days [ Time Frame: 90 days following cardiac arrest ]Number of patients who are known to be alive 90 days after the index cardiac arrest.
- Survival to 365 Days [ Time Frame: 365 days following cardiac arrest ]Number of patients who are alive 365 days after the index cardiac arrest.
- Neurological Recovery at Hospital Discharge, 30 Days, 90 Days, and 1 Year [Measured by Cerebral Performance Category (CPC), Overall Performance Category (OPC), and Health Utilities Index Mark 3 (HUI3); Cognitive Abilities Screening Instrument (CASI)] [ Time Frame: Various: hospital discharge through 1-year survival ]
|Study Start Date:||October 2005|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
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)
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.
Active Comparator: 2
Conventional standard cardiopulmonary resuscitation (S-CPR)
Procedure: Standard cardiopulmonary resuscitation (S-CPR)
Conventional standard cardiopulmonary resuscitation (S-CPR)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00189423
|United States, Indiana|
|Site 07: Indianapolis, IN|
|Indianapolis, Indiana, United States, 46202|
|United States, Michigan|
|Site 06: Washtenaw & Livingston Counties, MI|
|Ann Arbor, Michigan, United States, 48106|
|Site 04: Oakland & Macomb Counties, MI|
|Royal Oak, Michigan, United States, 48073|
|United States, Minnesota|
|Site 02: Minneapolis, MN|
|Minneapolis, Minnesota, United States, 55415|
|Site 01: St. Paul, MN|
|St. Paul, Minnesota, United States, 55101|
|United States, Washington|
|Site 03: Whatcom County, WA|
|Bellingham, Washington, United States, 98225|
|United States, Wisconsin|
|Site 05: Oshkosh, WI|
|Oshkosh, Wisconsin, United States, 54901|
|Principal Investigator:||Keith G. Lurie, MD||Advanced Circulatory Systems|