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.
No text entered.

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 ]

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:
  No text entered.
[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 ]

Measure Type Secondary
Measure Title Major Adverse Event Rate as Measured by Number of Adverse Events
Measure Description 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.
Time Frame Time from cardiac arrest through hospital discharge (an average of 12 days 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.
Population is a modified Intent to Treat (mITT) population consisting of patients who met all initial and 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  
Major Adverse Event Rate as Measured by Number of Adverse Events  
[units: patients]
  766     787  


Statistical Analysis 1 for Major Adverse Event Rate as Measured by Number of Adverse Events
Groups [1] Standard CPR
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Fisher Exact test, for non-inferiority
P Value [4] 0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  non-inferiority margin of 5%
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  p value is for non-inferiority with a margin of 5% (exact binomial test)

Statistical Analysis 2 for Major Adverse Event Rate as Measured by Number of Adverse Events
Groups [1] Standard CPR
Method [2] Fisher Exact
P Value [3] 0.681
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



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

Measure Type Secondary
Measure Title Return of Spontaneous Circulation (ROSC)
Measure Description Number of subjects who had ROSC reported during resuscitation in the field by EMS.
Time Frame Time of cardiac arrest until discontinuation of efforts  
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.
Population was a modified Intent to Treat (mITT) population that consisted of patients who met all initial and 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  
Return of Spontaneous Circulation (ROSC)  
[units: patients]
  324     343  

No statistical analysis provided for Return of Spontaneous Circulation (ROSC)



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

Measure Type Secondary
Measure Title Survival to Hospital (e.g., Intensive Care Unit) Admission
Measure Description Number of patients who survived to hospital or ICU admission after being transported to the emergency department (ED) after out-of-hospital cardiac arrest.
Time Frame Time of hospital admission, up to 1 day after cardiac arrest  
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.
Population is a modified Intent to Treat (mITT) population who received EMS CPR per study protocol after meeting initial inclusion criteria and also met 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  
Survival to Hospital (e.g., Intensive Care Unit) Admission  
[units: patients]
  216     237  

No statistical analysis provided for Survival to Hospital (e.g., Intensive Care Unit) Admission



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

Measure Type Secondary
Measure Title Survival to 24 Hours
Measure Description Number of patients who were alive 24 hours after the initial cardiac arrest.
Time Frame 24 hours following cardiac arrest  
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.
Population is a modified Intent to Treat (mITT) population who met ititial inclusion criteria and 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  
Survival to 24 Hours  
[units: patients]
  176     197  

No statistical analysis provided for Survival to 24 Hours



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

Measure Type Secondary
Measure Title Survival to Hospital Discharge
Measure Description No text entered.
Time Frame cardiac arrest 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.
No text entered.

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  
Survival to Hospital Discharge  
[units: patients]
  104     80  

No statistical analysis provided for Survival to Hospital Discharge



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

Measure Type Secondary
Measure Title Survival to 90 Days
Measure Description Number of patients who are known to be alive 90 days after the index cardiac arrest.
Time Frame 90 days following cardiac arrest  
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.
Population is a modified Intent to Treat (mITT) population that met initial and 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  
Survival to 90 Days  
[units: patients]
  58     87  

No statistical analysis provided for Survival to 90 Days



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

Measure Type Secondary
Measure Title Survival to 365 Days
Measure Description Number of patients who are alive 365 days after the index cardiac arrest.
Time Frame 365 days following cardiac arrest  
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.
Population is a modified Intent to Treat (mITT) population who met initial and 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  
Survival to 365 Days  
[units: patients]
  48     74  


Statistical Analysis 1 for Survival to 365 Days
Groups [1] Standard CPR
Method [2] Fisher Exact
P Value [3] 0.024
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



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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