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

This study is currently recruiting participants.
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
  Purpose

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).


Condition Intervention Phase
Out of Hospital Cardiac Arrest
Other: Comparison of 30:2 CPR versus continuous chest compressions
Other: Continuous chest compressions
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Trial Of Continuous Compressions Versus Standard CPR In Patients With Out-Of-Hospital Cardiac Arrest

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 23600
Study Start Date: June 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard CPR
American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations
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.
Experimental: Continuous chest compressions
Continuous compression CPR
Other: Continuous chest compressions
Continuous chest compressions during the first 6 minutes of the resuscitation.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01372748

Locations
United States, Alabama
Alabama Resuscitation Center Recruiting
Birmingham, Alabama, United States, 35294
Contact: Henry Wang, MD       hwang@uabmc.edu   
United States, Pennsylvania
The Pittsburgh Resuscitation Network, University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Clifton Callaway, MD       callawaycw@upmc.edu   
United States, Texas
Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Ahamed Idris, MD       aidris@sbcglobal.net   
United States, Washington
Seattle-King County Center for Resuscitation Research Recruiting
Seattle, Washington, United States, 98195-6422
Contact: Peter Kudenchuk, MD       kudenchu@u.washington.edu   
United States, Wisconsin
Milwaukee Resuscitation Network, Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Tom A Aufderheide, MD       taufderh@mcw.edu   
Canada, Ontario
University of Ottawa/University of British Columbia Collaborative RCC, Ottawa Health Research Recruiting
Ottawa, Ontario, Canada, K1Y 4E9
Contact: Ian Stiell, MD       istiell@ohri.ca   
Rescu Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Laurie Morrison, MD       MorrisonL@smh.ca   
Sponsors and Collaborators
University of Washington
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
Investigators
Study Chair: Myron Weisfeldt, MD, MD Johns Hopkins University
  More Information

Additional Information:
No publications provided

Responsible Party: Susanne May, Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT01372748     History of Changes
Other Study ID Numbers: 40404-B, 5U01HL077863-07
Study First Received: June 2, 2011
Last Updated: October 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
cardiac arrest
cardiopulmonary resuscitation

Additional relevant MeSH terms:
Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014