Continuous Chest Compressions vs AHA Standard CPR of 30:2

Out of Hospital Cardiac Arrest Clinical Trial

— CCC  

Official title:

Trial Of Continuous Compressions Versus Standard CPR In Patients With Out-Of-Hospital Cardiac Arrest

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01372748
• Other study ID #: 40404-B
• Secondary ID: 5U01HL077863-07
• Status: Completed
• Phase: Phase 4
• First received: June 2, 2011
• Last updated: November 30, 2015
• Start date: June 2011
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23711
• Est. completion date: November 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Arrest
• Out of Hospital Cardiac Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

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

Locations

Country	Name	City	State
Canada	University of Ottawa/University of British Columbia Collaborative RCC, Ottawa Health Research	Ottawa	Ontario
Canada	Rescu	Toronto	Ontario
United States	Alabama Resuscitation Center	Birmingham	Alabama
United States	Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center	Dallas	Texas
United States	Milwaukee Resuscitation Network, Medical College of Wisconsin	Milwaukee	Wisconsin
United States	The Pittsburgh Resuscitation Network, University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Seattle-King County Center for Resuscitation Research	Seattle	Washington

Sponsors (7)

Lead Sponsor	Collaborator
University of Washington	American Heart Association, Canadian Institutes of Health Research (CIHR), Defence Research and Development Canada, Heart and Stroke Foundation of Canada, National Heart, Lung, and Blood Institute (NHLBI), U.S. Army Medical Research and Materiel Command

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival 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. There is no average time frame for the hospitalization period as it may be less than one day or it can last 3-6 months.	Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first.	No
Secondary	Neurologic status at discharge using modified Rankin Score and adverse events.	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. There is no average time frame for the hospitalization period as it may be less than one day or it can last 3-6 months.	Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first.	Yes

External Links

•   Home page for Resuscitation Outcomes Consortium