Continuous Chest Compressions (CCC)
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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 |
- 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.
- 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
30:2 compressions to ventilations
|
Other: Comparison of 30:2 CPR versus continuous chest compressions
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.
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 |
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| 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 | |
| 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: | February 7, 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 May 19, 2013