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

Primary Purpose

Out of Hospital Cardiac Arrest

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Standard CPR
Continuous chest compressions
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Out of Hospital Cardiac Arrest focused on measuring cardiac arrest, cardiopulmonary resuscitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alabama Resuscitation Center
  • The Pittsburgh Resuscitation Network, University of Pittsburgh
  • Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center
  • Seattle-King County Center for Resuscitation Research
  • Milwaukee Resuscitation Network, Medical College of Wisconsin
  • University of Ottawa/University of British Columbia Collaborative RCC, Ottawa Health Research
  • Rescu

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard CPR

Continuous chest compressions

Arm Description

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

Continuous compression CPR

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 2, 2011
Last Updated
November 3, 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
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1. Study Identification

Unique Protocol Identification Number
NCT01372748
Brief Title
Continuous Chest Compressions vs AHA Standard CPR of 30:2
Acronym
CCC
Official Title
Trial Of Continuous Compressions Versus Standard CPR In Patients With Out-Of-Hospital Cardiac Arrest
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Out of Hospital Cardiac Arrest
Keywords
cardiac arrest, cardiopulmonary resuscitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23711 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard CPR
Arm Type
Active Comparator
Arm Description
American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations
Arm Title
Continuous chest compressions
Arm Type
Experimental
Arm Description
Continuous compression CPR
Intervention Type
Other
Intervention Name(s)
Standard CPR
Intervention Description
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
Intervention Name(s)
Continuous chest compressions
Intervention Description
Continuous chest compressions during the first 6 minutes of the resuscitation.
Primary Outcome Measure Information:
Title
Number of Participants Who Survive From the Time of Cardiac Arrest to Hospital Discharge
Description
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.
Time Frame
Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first.
Secondary Outcome Measure Information:
Title
Percentage of Participants Scoring at or Below a 3 on the MRS Scale
Description
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
Time Frame
Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myron Weisfeldt, MD, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Study Chair
Facility Information:
Facility Name
Alabama Resuscitation Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
The Pittsburgh Resuscitation Network, University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Facility Name
Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Seattle-King County Center for Resuscitation Research
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-6422
Country
United States
Facility Name
Milwaukee Resuscitation Network, Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
University of Ottawa/University of British Columbia Collaborative RCC, Ottawa Health Research
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Facility Name
Rescu
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
26550795
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.
Results Reference
derived
PubMed Identifier
25728722
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.
Results Reference
derived

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Continuous Chest Compressions vs AHA Standard CPR of 30:2

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