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Arrest Pac


 
  Current Research

THE RESQ TRIAL:

COMPARISON OF STANDARD CARDIOPULMONARY RESUSCITATION (S-CPR)
ALONE VERSUS ACTIVE COMPRESSION DECOMPRESSION CARDIOPULMONARY
RESUSCITATION (ACD-CPR) PLUS AN INSPIRATORY IMPEDANCE THRESHOLD DEVICE (ITD)
ON SURVIVAL FROM OUT-OF-HOSPITAL CARDIAC ARREST

The ResQ Trial is currently being conducted by Advanced Circulatory with funding support from the National Institute of Health. ACSI has obtained an investigational device exemption (IDE) and an exception from informed consent for emergency research from the Food and Drug Administration to conduct the trial.

Study Purpose: The objective of the clinical trial is to compare survival from cardiac arrest in patients receiving:
Control Group: conventional, manual standard cardiopulmonary resuscitation (S-CPR), performed with a pair of hands, to
Experimental Group: active compression decompression CPR (ACD-CPR; performed with the ResQPump) and an impedance threshold device (ITD; ResQPOD)

Study Design: This is a prehospital, prospective trial in which patients are randomized to either the control or experimental group by week. During S-CPR weeks, all patients presenting in cardiac arrest to EMS personnel and who meet study enrollment criteria receive S-CPR. During ACD-CPR + ITD weeks, all patients presenting in cardiac arrest to EMS personnel and who meet study enrollment criteria have CPR performed with the ResQPump and ResQPOD. All other aspects of patient care (airway management, IV fluids, medications, defibrillation, resuscitation length, etc.) are identical between the two groups. Rescuers, investigators and the sponsor are blinded to aggregate study results during the conduct of the trial.

Study Duration: This study enrolled its first subject in October 2005. The sponsor is working on adding a seventh site so that enrollment can be completed in 2009.

Study Devices: A device combination (ResQPump and ResQPOD) is being compared to conventional S-CPR.
 
The ResQPump™ is a hand-held device that is placed in the same position on the sternum as the hands are for S-CPR (mid-nipple line on the lower half of sternum). It allows rescuers to perform a similar chest compression (depth 1 ½ - 2”), but instead of allowing the chest wall to recoil passively, rescuers pull up on the handle with suction cup and provide active decompression of the chest, thereby assuring proper chest wall recoil and the creation of a negative intrathoracic pressure (vacuum) that helps return blood to the heart. The handle contains a force gauge and metronome that guide compression depth, recoil and rate.
The ResQPOD® is an impedance threshold device that selectively prevents unnecessary respiratory gases from the entering the chest during the chest wall recoil phase of CPR. It is attached within the ventilation circuit, between the airway adjunct (e.g. facemask, ET tube) and the ventilation source (e.g. ventilation bag). By selectively impeding airflow during CPR, it optimizes the intrathoracic vacuum that is generated during chest wall recoil, thereby increasing preload, and thus, cardiac output on the subsequent compression. There is no resistance to patient exhalation or rescuer ventilation. Timing assist lights help guide rescuers to ventilate at the proper rate.

Study Sites: The trial is being conducted in the following US sites:

Study Sponsor
Advanced Circulatory, Eden Prairie, Minnesota
Chief Medical Officer/Principal Investigator: Keith Lurie, MD

Site 01 – St. Paul, Minnesota
Principal Investigator: R. J. Frascone, MD (Regions Hospital EMS)
Agencies: St. Paul FD

Site 02 – Hennepin Co., Minnesota
Principal Investigator: Brian Mahoney, MD (Hennepin Co. EMS)
Agencies: Hennepin Co. Ambulance, Minneapolis FD and North Memorial Ambulance

Site 03 – Whatcom Co., Washington
Principal Investigator: Marvin Wayne, MD (Whatcom Co. EMS)
Agencies: Bellingham FD, Whatcom Co. EMS

Site 04 – Oakland & Macomb Co., Michigan
Principal Investigator: Robert Swor, DO (Beaumont Hospital)
Agencies: Alliance Mobile Health, Birmingham FD, Ferndale FD, Royal Oak FD, and Sterling Heights FD

Site 05 – Oshkosh, Wisconsin
Principal Investigator: Tom Aufderheide, MD (Medical College of WI)
Agencies: Oshkosh FD

Site 06 – Washtenaw and Livingston Co., Michigan
Principal Investigator: Bob Domeier, MD (St. Joseph Hospital)
Agencies: Numerous ambulance services and fire departments in Washtenaw and Livingston counties.

Site 07 – Indianapolis, Indiana (proposed for 2009)
Principal Investigator: Michael Olinger, MD (Wishard Hospital)
Agencies: Indianapolis FD, Carmel FD and Wishard Ambulance

Study Inclusion Criteria:
1. Adult initially presumed or known to be 18 years of age or older
2. Subjects who present with presumed non-traumatic, out-of-hospital cardiac arrest and who are candidates for resuscitation attempts

Study Exclusion Criteria:

  1. Subjects initially presumed or known to be < 18 years of age
  2. Subjects with obvious or likely traumatic injuries causing cardiac arrest
  3. Subjects with pre-existing DNR orders
  4. Subjects with signs of obvious clinical death or conditions that preclude the use of CPR
  5. Subjects whose family or legal guardians request that the subject not be entered in the study at the time of arrest.
  6. Subjects experiencing in-hospital cardiac arrest
  7. Recent sternotomy with wound not appearing completely healed (if unknown) or less than six months (if known)

Primary Study Outcome: The primary outcome for this trial is survival to hospital discharge with a Modified Rankin Scale score of 3 or better.

Secondary Study Outcomes:

  • Adverse event rates (e.g. death, rib fractures, organ injury, etc.)
  • Return of spontaneous circulation
  • Survival to hospital admission
  • Survival to 24 hours
  • Survival to hospital discharge
  • Survival to 30 days
  • Survival to 90 days
  • Survival to 1 year

Neurologic Assessments Performed on Survivors:

  • Modified Rankin Scale (MRS)
  • Cerebral Performance Category (CPC)
  • Overall Performance Category (OPC)
  • Health Utilities Index 3 (HUI-3)
  • Disability Rating Scale
  • Cognitive Abilities Screening Instrument (CASI)
  • Trail-Making Test
  • Beck Depression Inventory II (BDI-II)
  • Mayo-Portland Adaptability Inventory-4 (MPAI-4)
  • Quality of Life Survey

If you have questions about the ResQ Trial, please contact us at 651-403-5600.


 
Demo Kit

The generally cleared indication for the ResQPOD is a temporary increase in blood circulation during emergency care, hospital, clinic and home use. Research is ongoing in the United States to evaluate the long-term benefit of the ResQPOD for indications related to patients suffering from cardiac arrest.
 
For more information on completed clinical studies click here. The references on this website are not intended to imply specific outcome-based claims not yet cleared by the US Food and Drug Administration.
 

 
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