Continuous Chest Compressions vs AHA Standard CPR of 30:2

Phase 4

Completed

• Conditions: Out of Hospital Cardiac Arrest
• Interventions: Other: Continuous chest compressions; Other: Standard CPR

• Registration Number: NCT01372748
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-02
• Study First Submitted QC: 2011-06-13
• Study First Posted: 2011-06-14
• Primary Completion: 2015-08
• Study Completion: 2015-11
• Results First Submitted: 2016-08-08
• Results First Submitted QC: 2016-08-08
• Results First Posted: 2016-10-05
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-03
• Last Update Posted: 2016-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23711

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Continuous chest compressions	Continuous chest compressions	Continuous compression CPR
Standard CPR	Standard CPR	American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Survive From the Time of Cardiac Arrest to Hospital Discharge	Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first.	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

Name	Time	Method
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.	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

Trial Locations

Locations (7)

Seattle-King County Center for Resuscitation Research; 🇺🇸 Seattle, Washington, United States

Milwaukee Resuscitation Network, Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

Alabama Resuscitation Center; 🇺🇸 Birmingham, Alabama, United States

Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

The Pittsburgh Resuscitation Network, University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Rescu; 🇨🇦 Toronto, Ontario, Canada

University of Ottawa/University of British Columbia Collaborative RCC, Ottawa Health Research; 🇨🇦 Ottawa, Ontario, Canada