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
Results First Received: March 1, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Conditions: Heart Arrest
Death, Sudden, Cardiac
Cardiopulmonary Resuscitation
Cardiac Arrest
Interventions: Device: Use of an impedance threshold device (ITD) during the performance of active compression decompression CPR (ACD-CPR)
Procedure: Standard cardiopulmonary resuscitation (S-CPR)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted under a waiver of informed consent for emergency research that was approved by the U.S. Food and Drug Administration and by the Institutional Review Boards at participating study sites. All adults with out-of-hospital cardiac arrest were eligible for the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All sites were required to complete a run-in phase prior to to beginning randomization. A total of 197 patients were enrolled in the run-in phase across all sites. A total of 2470 patients were provisionally enrolled and received randomized CPR treatment. Of these, 1653 met the final selection criteria (non-traumatic arrest due to cardiac cause).

Reporting Groups
  Description
Standard CPR Conventional standard cardiopulmonary resuscitation (S-CPR)
ACD CPR Plus ITD Active compression decompression CPR plus an Impedance Threshold Device

Participant Flow:   Overall Study
    Standard CPR     ACD CPR Plus ITD  
STARTED     813     840  
COMPLETED     48     74  
NOT COMPLETED     765     766  
Death                 746                 747  
Withdrawal by Subject                 9                 9  
Lost to Follow-up                 10                 10  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Standard CPR Conventional standard cardiopulmonary resuscitation (S-CPR)
ACD CPR Plus ITD Active compression decompression CPR plus an Impedance Threshold Device
Total Total of all reporting groups

Baseline Measures
    Standard CPR     ACD CPR Plus ITD     Total  
Number of Participants  
[units: participants]
  813     840     1653  
Age  
[units: participants]
     
<=18 years     0     1     1  
Between 18 and 65 years     377     369     746  
>=65 years     436     470     906  
Age  
[units: years]
Mean ± Standard Deviation
  66.8  ± 14.5     67.0  ± 15.2     66.9  ± 14.9  
Gender  
[units: participants]
     
Female     274     282     556  
Male     539     558     1097  
Region of Enrollment  
[units: participants]
     
United States     813     840     1653  



  Outcome Measures
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1.  Primary:   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 ]
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Measure Type Primary
Measure Title Number of Patients Who Survived to Hospital Discharge With Favorable Neurologic Function Defined as MRS Score <=3
Measure Description 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  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The population was a modified Intent to Treat (mITT) population who received EMS CPR per study protocol after meeting initial inclusion criteria and who were finally included in the final analysis population after meeting final inclusion criteria.

Reporting Groups
  Description
Standard CPR Conventional standard cardiopulmonary resuscitation (S-CPR)
ACD CPR Plus ITD Active compression decompression CPR plus an Impedance Threshold Device

Measured Values
    Standard CPR     ACD CPR Plus ITD  
Number of Participants Analyzed  
[units: participants]
  813     840  
Number of Patients Who Survived to Hospital Discharge With Favorable Neurologic Function Defined as MRS Score <=3  
[units: patients]
  47     75  


Statistical Analysis 1 for Number of Patients Who Survived to Hospital Discharge With Favorable Neurologic Function Defined as MRS Score <=3
Groups [1] Standard CPR
Method [2] Fisher Exact
P Value [3] 0.019
Odds Ratio (OR) [4] 1.58
95% Confidence Interval ( 1.07 to 2.36 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
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[2] Other relevant method information, such as adjustments or degrees of freedom:
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[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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[4] Other relevant estimation information:
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2.  Secondary:   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 ]

3.  Secondary:   Return of Spontaneous Circulation (ROSC)   [ Time Frame: Time of cardiac arrest until discontinuation of efforts ]

4.  Secondary:   Survival to Hospital (e.g., Intensive Care Unit) Admission   [ Time Frame: Time of hospital admission, up to 1 day after cardiac arrest ]

5.  Secondary:   Survival to 24 Hours   [ Time Frame: 24 hours following cardiac arrest ]

6.  Secondary:   Survival to Hospital Discharge   [ Time Frame: cardiac arrest to hospital discharge ]

7.  Secondary:   Survival to 90 Days   [ Time Frame: 90 days following cardiac arrest ]

8.  Secondary:   Survival to 365 Days   [ Time Frame: 365 days following cardiac arrest ]

9.  Secondary:   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 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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