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Circulation Improving Resuscitation Care (CIRC) (CIRC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00597207
First Posted: January 17, 2008
Last Update Posted: September 26, 2017
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.
Collaborator:
Ullevaal University Hospital
Information provided by (Responsible Party):
Zoll Medical Corporation
Results First Submitted: March 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Cardiac Arrest
Cardiopulmonary Resuscitation
Interventions: Device: AutoPulse
Other: Manual

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
iA-CPR

Integrated Mechanical CPR with AutoPulse All subjects initially receive manual chest compressions. After randomization, subjects randomized to iA-CPR are moved to the device once it is ready and from thereon receive mechanical chest compressions.

AutoPulse: Mechanical device that provides chest compression

M-CPR

Manual CPR All subjects initially receive manual chest compressions. After randomization, subjects randomized to M-CPR continue to receive manual chest compressions.

Manual: Manual chest compression


Participant Flow:   Overall Study
    iA-CPR   M-CPR
STARTED   2099   2132 
COMPLETED   2094   2125 
NOT COMPLETED   5   7 
Lost to Follow-up                5                7 



  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
iA-CPR

Integrated Mechanical CPR with AutoPulse All subjects initially receive manual chest compressions. After randomization, subjects randomized to iA-CPR are moved to the device once it is ready and from thereon receive mechanical chest compressions.

AutoPulse: Mechanical device that provides chest compression

M-CPR

Manual CPR All subjects initially receive manual chest compressions. After randomization, subjects randomized to M-CPR continue to receive manual chest compressions.

Manual: Manual chest compression

Total Total of all reporting groups

Baseline Measures
   iA-CPR   M-CPR   Total 
Overall Participants Analyzed 
[Units: Participants]
 2099   2132   4231 
Age, Customized 
[Units: Participants]
     
18-59 years   706   734   1440 
60-74 years   671   689   1360 
75+ years   722   709   1431 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      784  37.4%      837  39.3%      1621  38.3% 
Male      1315  62.6%      1295  60.7%      2610  61.7% 


  Outcome Measures

1.  Primary:   Hospital Discharge   [ Time Frame: From time of first contact until hospital discharge, up to 90 days. ]

2.  Secondary:   Neurology   [ Time Frame: 30 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Sustained ROSC, Survival to 24 Hours, Hospital Discharge With a MRS ≤ 3, Process Outcomes: Number of Shocks, Duration of Pulselessness From 911 Call to ROSC, Hands-on Interval or Other Measures of CPR Quality   [ Time Frame: during the case ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Sr. Director of Clinical Research
Organization: ZOLL Medical Corporation
phone: 978-421-9655
e-mail: uherken@zoll.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Zoll Medical Corporation
ClinicalTrials.gov Identifier: NCT00597207     History of Changes
Other Study ID Numbers: Zoll-0100
First Submitted: January 8, 2008
First Posted: January 17, 2008
Results First Submitted: March 8, 2014
Results First Posted: April 14, 2014
Last Update Posted: September 26, 2017