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

This study has been terminated.
(Terminated due to lack of funding. Follow-up completed for all enrolled subjects.)
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Advanced Circulatory Systems
ClinicalTrials.gov Identifier:
NCT00189423
First received: September 12, 2005
Last updated: July 12, 2016
Last verified: July 2016
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 
Overall Participants Analyzed 
[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 ]

2.  Secondary:   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 ]

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 reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events
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Time Frame No text entered.
Additional Description 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

Serious Adverse Events
    Standard CPR   ACD CPR Plus ITD
Total, serious adverse events     
# participants affected / at risk   766/813 (94.22%)   787/840 (93.69%) 
General disorders     
death     
# participants affected / at risk   729/813 (89.67%)   734/840 (87.38%) 
# events   729   734 
re-arrest     
# participants affected / at risk   161/813 (19.80%)   184/840 (21.90%) 
# events   161   184 
seizure     
# participants affected / at risk   13/813 (1.60%)   11/840 (1.31%) 
# events   13   11 
bleeding requiring intervention     
# participants affected / at risk   3/813 (0.37%)   7/840 (0.83%) 
# events   3   7 
cerebral bleeding     
# participants affected / at risk   3/813 (0.37%)   2/840 (0.24%) 
# events   3   2 
internal organ injury     
# participants affected / at risk   0/813 (0.00%)   1/840 (0.12%) 
# events   0   1 
Respiratory, thoracic and mediastinal disorders     
pulmonary edema     
# participants affected / at risk   62/813 (7.63%)   93/840 (11.07%) 
# events   62   93 
rib/sterna fracture     
# participants affected / at risk   14/813 (1.72%)   11/840 (1.31%) 
# events   14   11 
pneumothorax     
# participants affected / at risk   7/813 (0.86%)   10/840 (1.19%) 
# events   7   10 
hemothorax     
# participants affected / at risk   1/813 (0.12%)   2/840 (0.24%) 
# events   1   2 




  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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