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Trial record 2 of 2 for:    lurie cpr

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00189423
Recruitment Status : Terminated (Terminated due to lack of funding. Follow-up completed for all enrolled subjects.)
First Posted : September 19, 2005
Results First Posted : August 22, 2012
Last Update Posted : December 8, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Advanced Circulatory Systems

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 19, 2005
Results First Submitted Date  ICMJE March 1, 2012
Results First Posted Date  ICMJE August 22, 2012
Last Update Posted Date December 8, 2017
Study Start Date  ICMJE October 2005
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
Survival to hospital discharge with good neurologic recovery (Modified Rankin Score 3 or less)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2017)
  • 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 1 Year [Measured by Cognitive Abilities Screening Instrument (CASI)] [ Time Frame: One year after index arrest ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • Rate of adverse events
  • Return of Spontaneous Circulation (ROSC)
  • Survival to 1 hour
  • Survival to hospital (e.g. intensive care unit) admission
  • Survival to 24 Hours
  • Survival to 30 days
  • Survival to 90 Days
  • Survival to 365 Days
  • Neurological recovery at hospital discharge, 30 days, 90 days and one year; as measured by: Cerebral Performance Category (CPC), Overall Performance Category (OPC) and Health Utilities Index Mark 3 (HUI3); Cognitive Abilities Screening Instrument (CASI),
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ResQ Trial: Impact of an ITD and Active Compression Decompression CPR on Survival From Out-of-Hospital Cardiac Arrest
Official Title  ICMJE ResQ Trial: Comparison of Standard CPR Alone Versus Active Compression Decompression CPR Plus an ITD on Survival From Out-of-Hospital Cardiac Arrest
Brief Summary 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

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Heart Arrest
  • Death, Sudden, Cardiac
  • Cardiopulmonary Resuscitation
  • Cardiac Arrest
Intervention  ICMJE
  • 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
  • Procedure: Standard cardiopulmonary resuscitation (S-CPR)
    Conventional standard cardiopulmonary resuscitation (S-CPR)
Study Arms  ICMJE
  • Experimental: 1
    Active compression decompression cardiopulmonary resuscitation (ACD-CPR) with an impedance threshold device (ITD)
    Intervention: Device: Use of an impedance threshold device (ITD) during the performance of active compression decompression CPR (ACD-CPR)
  • Active Comparator: 2
    Conventional standard cardiopulmonary resuscitation (S-CPR)
    Intervention: Procedure: Standard cardiopulmonary resuscitation (S-CPR)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 18, 2012)
1653
Original Enrollment  ICMJE
 (submitted: September 12, 2005)
2450
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00189423
Other Study ID Numbers  ICMJE 265
R44HL065851-03 ( U.S. NIH Grant/Contract )
2R44HL065851-03 ( U.S. NIH Grant/Contract )
43-0303-000
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Advanced Circulatory Systems
Study Sponsor  ICMJE Advanced Circulatory Systems
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Keith G. Lurie, MD Advanced Circulatory Systems
PRS Account Advanced Circulatory Systems
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP