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Continuous Chest Compressions vs AHA Standard CPR of 30:2 (CCC)

This study has been completed.
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Canada
American Heart Association
Defence Research and Development Canada
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
Susanne May, University of Washington
ClinicalTrials.gov Identifier:
NCT01372748
First received: June 2, 2011
Last updated: August 8, 2016
Last verified: August 2016
Results First Received: August 8, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Out of Hospital Cardiac Arrest
Interventions: Other: Standard CPR
Other: Continuous chest compressions

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Standard CPR

American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations

Standard CPR: 30:2 CPR consists of 3 cycles of standard CPR with each cycle consisting of 30 chest compressions with a pause for 2 ventilations at a compression:ventilation ratio of 30:2. CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation. In either group, each cycle will be followed by rhythm analysis until three cycles are completed or restoration of spontaneous circulation (ROSC), whichever occurs first.

Continuous Chest Compressions

Continuous compression CPR

Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation.


Participant Flow:   Overall Study
    Standard CPR   Continuous Chest Compressions
STARTED   11045   12642 
COMPLETED   11022 [1]   12603 [1] 
NOT COMPLETED   23   39 
Lost to Follow-up                16                34 
Withdrawal by Subject                7                5 
[1] defined as having vital status



  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

American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations

Standard CPR: 30:2 CPR consists of 3 cycles of standard CPR with each cycle consisting of 30 chest compressions with a pause for 2 ventilations at a compression:ventilation ratio of 30:2. CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation. In either group, each cycle will be followed by rhythm analysis until three cycles are completed or restoration of spontaneous circulation (ROSC), whichever occurs first.

Continuous Chest Compressions

Continuous compression CPR

Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation.

Total Total of all reporting groups

Baseline Measures
   Standard CPR   Continuous Chest Compressions   Total 
Overall Participants Analyzed 
[Units: Participants]
 11045   12642   23687 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.2  (17.0)   66.4  (17.2)   66.3  (17.1) 
Gender 
[Units: Participants]
     
Female   3926   4618   8544 
Male   7119   8024   15143 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   14   12   26 
Asian   123   140   263 
Native Hawaiian or Other Pacific Islander   23   28   51 
Black or African American   1246   1350   2596 
White   1795   1931   3726 
More than one race   3   1   4 
Unknown or Not Reported   7841   9180   17021 
Region of Enrollment 
[Units: Participants]
     
Canada   6711   8010   14721 
United States   4334   4632   8966 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Survival to Hospital Discharge.   [ Time Frame: Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first. ]

2.  Secondary:   Neurologic Status at Discharge Using Modified Rankin Score and Adverse Events.   [ Time Frame: Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first. ]


  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: Dr. Susanne May
Organization: University of Washington, Resuscitation Outcomes Consortium
phone: 206-685-1302
e-mail: rochelp@uwctc.org


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

Responsible Party: Susanne May, University of Washington
ClinicalTrials.gov Identifier: NCT01372748     History of Changes
Other Study ID Numbers: 40404-B
5U01HL077863-07 ( US NIH Grant/Contract Award Number )
Study First Received: June 2, 2011
Results First Received: August 8, 2016
Last Updated: August 8, 2016
Health Authority: United States: Institutional Review Board