NCT01372748

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23,711

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2011

Longer than P75 for phase_4

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 14, 2011

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
11 months until next milestone

Results Posted

Study results publicly available

October 5, 2016

Completed
Last Updated

December 28, 2016

Status Verified

November 1, 2016

Enrollment Period

4.2 years

First QC Date

June 2, 2011

Results QC Date

August 8, 2016

Last Update Submit

November 3, 2016

Conditions

Out of Hospital Cardiac Arrest

Keywords

cardiac arrestcardiopulmonary resuscitation

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Survive From the Time of Cardiac Arrest to Hospital Discharge

    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.

    Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first.

Secondary Outcomes (1)

  • Percentage of Participants Scoring at or Below a 3 on the MRS Scale

    Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first.

Study Arms (2)

Standard CPR

ACTIVE COMPARATOR

American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations

Other: Standard CPR

Continuous chest compressions

EXPERIMENTAL

Continuous compression CPR

Other: Continuous chest compressions

Interventions

Standard CPROTHER

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.

Standard CPR
Continuous chest compressionsOTHER

Continuous chest compressions during the first 6 minutes of the resuscitation.

Continuous chest compressions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Alabama Resuscitation Center

Birmingham, Alabama, 35294, United States

Location

The Pittsburgh Resuscitation Network, University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

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

Dallas, Texas, 75390, United States

Location

Seattle-King County Center for Resuscitation Research

Seattle, Washington, 98195-6422, United States

Location

Milwaukee Resuscitation Network, Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

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

Ottawa, Ontario, K1Y 4E9, Canada

Location

Rescu

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (2)

  • 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.

    PMID: 26550795DERIVED

  • 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.

    PMID: 25728722DERIVED

MeSH Terms

Conditions

Out-of-Hospital Cardiac ArrestHeart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Dr. Susanne May
Organization
University of Washington, Resuscitation Outcomes Consortium
rochelp@uwctc.org
206-685-1302

Study Officials

  • Myron Weisfeldt, MD, MD

    Johns Hopkins University

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 2, 2011

First Posted

June 14, 2011

Study Start

June 1, 2011

Primary Completion

August 1, 2015

Study Completion

November 1, 2015

Last Updated

December 28, 2016

Results First Posted

October 5, 2016

Record last verified: 2016-11

Locations

US(5)CA(2)