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

Abstract

The Resuscitation Outcomes Consortium is conducting a randomized trial comparing survival to hospital discharge after continuous chest compressions (CCC) without interruption for ventilation versus currently recommended American Heart Association cardiopulmonary resuscitation (CPR) with interrupted chest compressions (ICC) in adult patients with out-of-hospital cardiac arrest (OHCA) without obvious trauma or respiratory cause. Emergency medical services perform study CPR for three intervals of manual chest compressions (each about 2 minutes), or until restoration of spontaneous circulation (ROSC). Patients randomized to the CCC intervention receive 200 chest compressions with positive pressure ventilations at a rate of 10/minute without interruption in compressions. those randomized to the ICC study arm receive chest compressions interrupted for positive pressure ventilations at a compression:ventilation ratio of 30:2. In either group, each interval of compressions is followed by rhythm analysis and defibrillation as required. Insertion of an advanced airway is deferred for at least the first 6 minutes to reduce interruptions in either study arm. The study uses a cluster randomized design with every-six-month crossovers. The primary outcome is survival to hospital discharge. Secondary outcomes are neurologically intact survival and adverse events. A maximum of 23,600 patients (11,800 per group) enrolled during the post-run-in phase of the study will provide at least 90% power to detect a relative change of 16% in the rate of survival to discharge; 8.1% to 9.4% with overall significance level of 0.05. If this trial demonstrates improved survival with either strategy, more than 3,000 premature deaths from cardiac arrest would be averted annually.

EuReCa and international resuscitation registries

“…Epidemiological studies such as the Resuscitation Outcomes Study provide insights into well defined characteristics and outcomes in a specific population [8 & ] as well as providing the critical mass of patients required to test clinical hypotheses [9].…”

Design and implementation of the Resuscitation Outcomes Consortium Pragmatic Airway Resuscitation Trial (PART)

“…The recently completed ROC Continuous Chest Compressions Trial enrolled almost 24,000 subjects. 36,37 By focusing on the more proximal outcome 72-hour survival, PART will require <3,000 enrolled subjects. The focus on 72-hour survival supports the pragmatic notion that prehospital interventions may be more closely aligned with proximal than more distant outcomes.…”

“…36,37 The available grant support did not allow for the execution of such a large trial. Prior OHCA trials have used return of spontaneous circulation, survival to hospital admission, and 24-hour survival as primary outcomes, but this strategy overlooks post-arrest care elements common in current practice: a) the delivery of therapeutic hypothermia (targeted temperature management), which typically requires 48–72 hours, b) early percutaneous coronary intervention, and c) delay of neurologic assessment and withdraw of care decisions until at least 72 hours after the cardiac arrest event.…”

A Local Sensitivity Analysis of the Trial of Continuous or Interrupted Chest Compressions during Cardiopulmonary Resuscitation: Is a Local Protocol Change Required?

“…The methods of the CCC Trial ( ClinicalTrials.gov Identifier: NCT01372748) have been previously described [ 2 ] and results reported [ 1 ]. Eight Resuscitation Outcomes Consortium sites, including 114 EMS agencies, performed this study of a cluster-randomized design with twice-yearly crossovers.…”