Clinical trial NCT01372748: Continuous Chest Compressions vs AHA Standard CPR of 30:2
Official title: Trial Of Continuous Compressions Versus Standard CPR In Patients With Out-Of-Hospital Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Out of Hospital Cardiac Arrest
Keywords: cardiac arrest
cardiopulmonary resuscitation
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Canadian Institutes of Health Research (CIHR)
name: Heart and Stroke Foundation of Canada
name: American Heart Association
name: Defence Research and Development Canada
name: U.S. Army Medical Research and Development Command
First posted: 2011-06-14
Enrollment: 23711
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

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 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

Primary outcomes:
measure: Number of Participants Who Survive From the Time of Cardiac Arrest to Hospital Discharge
timeFrame: Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first.
Secondary outcomes:
measure: Percentage of Participants Scoring at or Below a 3 on the MRS Scale
timeFrame: Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Resuscitation Center
state: Alabama
city: Pittsburgh
country: United States
facility: The Pittsburgh Resuscitation Network, University of Pittsburgh
state: Pennsylvania
city: Dallas
country: United States
facility: Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center
state: Texas
city: Seattle
country: United States
facility: Seattle-King County Center for Resuscitation Research
state: Washington
city: Milwaukee
country: United States
facility: Milwaukee Resuscitation Network, Medical College of Wisconsin
state: Wisconsin
city: Ottawa
country: Canada
facility: University of Ottawa/University of British Columbia Collaborative RCC, Ottawa Health Research
state: Ontario
city: Toronto
country: Canada
facility: Rescu
state: Ontario
Study officials:
affiliation: Johns Hopkins University
name: Myron Weisfeldt, MD, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.