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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of Washington
Sponsor:
Collaborators:
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: October 21, 2013
Last verified: October 2013

June 2, 2011
October 21, 2013
June 2011
June 2014   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Patients may die in the field (outside of the hospital at the time of the cardiac arrest), at the emergency room, in the hospital, or they are discharged alive from the hospital. There is no average time frame for the hospitalization period as it may be less than one day or it can last 3-6 months.
Same as current
Complete list of historical versions of study NCT01372748 on ClinicalTrials.gov Archive Site
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. ] [ Designated as safety issue: Yes ]
Patients may die in the field (outside of the hospital at the time of the cardiac arrest), at the emergency room, in the hospital, or they are discharged alive from the hospital. There is no average time frame for the hospitalization period as it may be less than one day or it can last 3-6 months.
Same as current
Not Provided
Not Provided
 
Continuous Chest Compressions vs AHA Standard CPR of 30:2
Trial Of Continuous Compressions Versus Standard CPR In Patients With Out-Of-Hospital Cardiac Arrest

The primary aim of the trial is to compare survival to hospital discharge after continuous chest compressions (CCC) versus standard American Heart Association (AHA) recommended cardiopulmonary resuscitation (CPR) with interrupted chest compressions (ICC) in patients with out-of-hospital cardiac arrest (OOHCA). The primary null hypothesis will be that the rate of survival to hospital discharge is not affected by use of continuous compressions with passive or positive pressure ventilation (intervention group) versus CPR with compressions interrupted for ventilation at a ratio of 30:2 (control group).

The primary aim of the trial is to compare survival to hospital discharge after continuous chest compressions (CCC) versus standard American Heart Association (AHA) recommended cardiopulmonary resuscitation (CPR) with interrupted chest compressions (ICC) in patients with out-of-hospital cardiac arrest (OOHCA). For this study, CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation followed by rhythm analysis or until restoration of spontaneous circulation (ROSC), whichever occurs first. ICC consists of series of three cycles of standard CPR each cycle comprised of chest compressions with interposed ventilations at a compression:ventilation ratio of 30:2 (per AHA guidelines) followed by rhythm analysis or until ROSC, whichever occurs first. In either patient group, the duration of manual CPR before the first rhythm analysis will be 30 seconds or 120 seconds. This treatment period will be followed by two cycles of compressions then rhythm analysis (i.e. each of approximately 2 minutes duration) in either group. Other aims of the trial are to compare survival to discharge among patients grouped by first-recorded rhythm or other a priori subgroups, as well as to compare neurological status at discharge, mechanistic outcomes or adverse events between control and intervention groups.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Out of Hospital Cardiac Arrest
  • Other: Comparison of 30:2 CPR versus continuous chest compressions
    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.
  • Other: Continuous chest compressions
    Continuous chest compressions during the first 6 minutes of the resuscitation.
  • Active Comparator: Standard CPR
    American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations
    Interventions:
    • Other: Comparison of 30:2 CPR versus continuous chest compressions
    • Other: Continuous chest compressions
  • Experimental: Continuous chest compressions
    Continuous compression CPR
    Intervention: Other: Continuous chest compressions
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
23600
October 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 years or more (or local age of consent);
  • Initial fire/Emergency Medical Services (EMS) chest compressions provided by Resuscitation Outcomes Consortium (ROC) study participating agency dispatched to the scene;
  • Lack of the exclusion criteria below

Exclusion Criteria:

  • EMS witnessed arrest;
  • Written do not attempt resuscitation (DNAR) orders;
  • Obvious primary asphyxia or respiratory cause of arrest (drowning, strangulation, hanging)
  • Advanced airway placed prior to ROC EMS arrival, or pre-existing tracheostomy
  • Traumatic cause (blunt, penetrating, burn) of arrest;
  • Known prisoners;
  • Known pregnancy;
  • Uncontrolled bleeding or exsanguination
  • Mechanical compression device used during study-assigned compression cycles
Both
18 Years and older
No
United States,   Canada
 
NCT01372748
40404-B, 5U01HL077863-07
Yes
Susanne May, University of Washington
University of Washington
  • 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
Study Chair: Myron Weisfeldt, MD, MD Johns Hopkins University
University of Washington
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP