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Completed

NCT Number: NCT01372748

Continuous Chest Compressions vs AHA Standard CPR of 30:2

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard CPR

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

Other

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

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • 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 Development Command

Registry information

Official study title

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

Acronym: CCC

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jun 14, 2011
Registry last updated
Dec 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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