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Continuous Chest Compressions vs AHA Standard CPR of 30:2

NCT ID: NCT01372748

Last Updated: 2016-12-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

23711 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2015-11-30

Brief Summary

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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

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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.

Conditions

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Out of Hospital Cardiac Arrest

Keywords

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cardiac arrest cardiopulmonary resuscitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard CPR

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

Group Type ACTIVE_COMPARATOR

Standard CPR

Intervention Type OTHER

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.

Continuous chest compressions

Continuous compression CPR

Group Type EXPERIMENTAL

Continuous chest compressions

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Continuous chest compressions

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

Intervention Type OTHER

Eligibility Criteria

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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;

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Heart and Stroke Foundation of Canada

OTHER

Sponsor Role collaborator

American Heart Association

OTHER

Sponsor Role collaborator

Defence Research and Development Canada

INDUSTRY

Sponsor Role collaborator

U.S. Army Medical Research and Development Command

FED

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Susanne May

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Myron Weisfeldt, MD, MD

Role: STUDY_CHAIR

Johns Hopkins University

Locations

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Alabama Resuscitation Center

Birmingham, Alabama, United States

Site Status

The Pittsburgh Resuscitation Network, University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

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

Dallas, Texas, United States

Site Status

Seattle-King County Center for Resuscitation Research

Seattle, Washington, United States

Site Status

Milwaukee Resuscitation Network, Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

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

Ottawa, Ontario, Canada

Site Status

Rescu

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

References

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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.

Reference Type DERIVED
PMID: 26550795 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25728722 (View on PubMed)

Other Identifiers

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5U01HL077863-07

Identifier Type: NIH

Identifier Source: secondary_id

View Link

40404-B

Identifier Type: -

Identifier Source: org_study_id