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

• ClinicalTrials.gov Identifier: NCT01372748
• Recruitment Status: Completed
• First Posted: June 14, 2011
• Results First Posted: October 5, 2016
• Last Update Posted: December 28, 2016
• 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 Development Command
• Information provided by (Responsible Party): Susanne May, University of Washington

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Out of Hospital Cardiac Arrest	Other: Standard CPR; Other: Continuous chest compressions	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 23711 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Trial Of Continuous Compressions Versus Standard CPR In Patients With Out-Of-Hospital Cardiac Arrest
• Study Start Date: June 2011
• Actual Primary Completion Date: August 2015
• Actual Study Completion Date: November 2015

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Standard CPR; American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations	Other: 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.
Experimental: Continuous chest compressions; Continuous compression CPR	Other: Continuous chest compressions; Continuous chest compressions during the first 6 minutes of the resuscitation.

Outcome Measures

Primary Outcome Measures :

1. Number of Participants Who Survive From the Time of Cardiac Arrest to Hospital Discharge [ Time Frame: Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first. ]
   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.

Secondary Outcome Measures :

1. Percentage of Participants Scoring at or Below a 3 on the MRS Scale [ Time Frame: Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first. ]
   Neurologic status at discharge will be assessed using the modified Rankin Score (MRS). A higher value indicates a worse outcome. 0-No symptoms at all; 1-No significant disability despite symptoms; able to carry out all usual duties and activities, 2-Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, 3-Moderate disability; requiring some help, but able to walk without assistance; 4-Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, 5-Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6-Dead

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Alabama

Alabama Resuscitation Center

Birmingham, Alabama, United States, 35294

United States, Pennsylvania

The Pittsburgh Resuscitation Network, University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15261

United States, Texas

Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

United States, Washington

Seattle-King County Center for Resuscitation Research

Seattle, Washington, United States, 98195-6422

United States, Wisconsin

Milwaukee Resuscitation Network, Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Canada, Ontario

University of Ottawa/University of British Columbia Collaborative RCC, Ottawa Health Research

Ottawa, Ontario, Canada, K1Y 4E9

Rescu

Toronto, Ontario, Canada, M5B 1W8

Sponsors and Collaborators

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 Development Command

Investigators

• Study Chair: Myron Weisfeldt, MD, MD; Johns Hopkins University

More Information

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

Nichol G, Leroux B, Wang H, Callaway CW, Sopko G, Weisfeldt M, Stiell I, Morrison LJ, Aufderheide TP, Cheskes S, Christenson J, Kudenchuk P, Vaillancourt C, Rea TD, Idris AH, Colella R, Isaacs M, Straight R, Stephens S, Richardson J, Condle J, Schmicker RH, Egan D, May S, Ornato JP; ROC Investigators. Trial of Continuous or Interrupted Chest Compressions during CPR. N Engl J Med. 2015 Dec 3;373(23):2203-14. doi: 10.1056/NEJMoa1509139. Epub 2015 Nov 9.

Brown SP, Wang H, Aufderheide TP, Vaillancourt C, Schmicker RH, Cheskes S, Straight R, Kudenchuk P, Morrison L, Colella MR, Condle J, Gamez G, Hostler D, Kayea T, Ragsdale S, Stephens S, Nichol G; ROC Investigators. A randomized trial of continuous versus interrupted chest compressions in out-of-hospital cardiac arrest: rationale for and design of the Resuscitation Outcomes Consortium Continuous Chest Compressions Trial. Am Heart J. 2015 Mar;169(3):334-341.e5. doi: 10.1016/j.ahj.2014.11.011. Epub 2014 Nov 20.

• Responsible Party: Susanne May, Principal Investigator, University of Washington
• ClinicalTrials.gov Identifier: NCT01372748
• Other Study ID Numbers: 40404-B; 5U01HL077863-07 ( U.S. NIH Grant/Contract )
• First Posted: June 14, 2011
• Results First Posted: October 5, 2016
• Last Update Posted: December 28, 2016
• Last Verified: November 2016

Keywords provided by Susanne May, University of Washington:

cardiac arrest; cardiopulmonary resuscitation

Additional relevant MeSH terms:

Heart Arrest; Out-of-Hospital Cardiac Arrest; Heart Diseases; Cardiovascular Diseases