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

This study has been terminated.
(Terminated due to lack of funding. Follow-up completed for all enrolled subjects.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Advanced Circulatory Systems
ClinicalTrials.gov Identifier:
NCT00189423
First received: September 12, 2005
Last updated: July 18, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Advanced Circulatory Systems:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Major Adverse Event Rate as Measured by Number of Adverse Events [ Time Frame: Time from cardiac arrest through hospital discharge (an average of 12 days for subjects surviving to hospital discharge ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Number of subjects who had ROSC 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Number of patients who were alive 24 hours after the initial cardiac arrest.

  • Survival to Hospital Discharge [ Time Frame: cardiac arrest to hospital discharge ] [ Designated as safety issue: Yes ]
  • Survival to 90 Days [ Time Frame: 90 days following cardiac arrest ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

Enrollment: 1653
Study Start Date: October 2005
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.

Other Names:
  • Impedance threshold device: ResQPOD CE CA
  • Device used to perform ACD-CPR: ResQPump
Active Comparator: 2
Conventional standard cardiopulmonary resuscitation (S-CPR)
Procedure: Standard cardiopulmonary resuscitation (S-CPR)
Conventional standard cardiopulmonary resuscitation (S-CPR)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189423

Locations
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
Sponsors and Collaborators
Advanced Circulatory Systems
Investigators
Principal Investigator: Keith G. Lurie, MD Advanced Circulatory Systems
  More Information

Additional Information:
Publications:

Responsible Party: Advanced Circulatory Systems
ClinicalTrials.gov Identifier: NCT00189423     History of Changes
Obsolete Identifiers: NCT00225953
Other Study ID Numbers: 265, R44HL065851-03, 2 R44HL065851-03, 43-0303-000
Study First Received: September 12, 2005
Results First Received: March 1, 2012
Last Updated: July 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Advanced Circulatory Systems:
Heart Arrest
Cardiac Arrest
Cardiopulmonary Resuscitation
Impedance Threshold Device
Active Compression Decompression
ResQPOD
ResQPump
Survival
Out-of-hospital
Prehospital
ResQCPR System

Additional relevant MeSH terms:
Death, Sudden
Heart Arrest
Death, Sudden, Cardiac
Out-of-Hospital Cardiac Arrest
Death
Pathologic Processes
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014