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| Sponsor: | University of Washington |
|---|---|
| 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 |
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 IV |
| 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 |
| 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.
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Experimental: Continuous chest compressions
Continuous compression CPR
|
Other: Continuous chest compressions
Continuous chest compressions during the first 6 minutes of the resuscitation.
|
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:
Exclusion Criteria:
Contacts and Locations| United States, Alabama | |
| Alabama Resuscitation Center | Not yet recruiting |
| Birmingham, Alabama, United States, 35294 | |
| United States, Pennsylvania | |
| The Pittsburgh Resuscitation Network, University of Pittsburgh | Not yet recruiting |
| Pittsburgh, Pennsylvania, United States, 15261 | |
| United States, Texas | |
| Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center | Not yet recruiting |
| Dallas, Texas, United States, 75390 | |
| United States, Washington | |
| Seattle-King County Center for Resuscitation Research | Not yet recruiting |
| Seattle, Washington, United States, 98195-6422 | |
| United States, Wisconsin | |
| Milwaukee Resuscitation Network, Medical College of Wisconsin | Not yet recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Canada, Ontario | |
| University of Ottawa/University of British Columbia Collaborative RCC, Ottawa Health Research | Not yet recruiting |
| Ottawa, Ontario, Canada, K1Y 4E9 | |
| 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
| 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: | December 30, 2011 |
| Health Authority: | United States: OHRP; United States: Institutional Review Board |
|
cardiac arrest cardiopulmonary resuscitation |
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Heart Arrest Out-of-Hospital Cardiac Arrest Heart Diseases Cardiovascular Diseases |