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PaRAMeDIC: a randomized controlled trial of a mechanical compression device

12 January 2012
Features
02 January 2012
Volume 4 · Issue 1

Abstract

Survival from out-of-hospital cardiac arrest (OHCA) is influenced by the quality of cardiopulmonary resuscitation (CPR). However, research shows that in the out-of-hospital environment, and particularly during ambulance transport, CPR quality is frequently sub-optimal. Mechanical compression devices can deliver high quality CPR, yet there is an absence of high quality evidence to demonstrate improved clinical or cost effectiveness outcomes. The PaRAMeDIC trial will compare manual CPR with mechanical CPR in adult patients with non-traumatic OHCA. Objectives: the primary objective is to evaluate the effectiveness of mechanical chest compressions using the LUCAS (Lund University Cardiopulmonary Assistance System)-2 on mortality at 30 days post-OHCA. Secondary objectives include survived event (return of spontaneous circulation at hospital admission), quality of life and cognitive function at 3 and 12 months, survival at 12 months and cost effectiveness. Method: the trial is a pragmatic, cluster randomized controlled trial. Ambulance vehicles are randomized to control or LUCAS arms. Patient allocation is determined by the first ambulance vehicle which arrives first on scene (manual CPR vehicle or LUCAS CPR vehicle). The trial will assess the clinical and cost effectiveness of the LUCAS-2 device. Trial Registration: The trial is registered on the International Standard Randomised Controlled Trial Number Registry (ISRCTN08233942).

Sudden cardiac death is a major cause of death and morbidity in the Western world. In Europe, approximately 700 000 people sustain a cardiac arrest in the community each year (Berdowski et al, 2010). Only around 5% of these patients survive to hospital discharge year (Berdowski et al, 2010). Many survivors have acceptable health-related quality of life (Elliot et al, 2011), which emphasizes the importance of optimizing early treatments aimed at achieving return of spontaneous circulation (ROSC) and survival to hospital discharge.

In the UK, a national audit of ambulance services (Evans, 2005) identified 57 345 out-of-hospital cardiac arrests (OHCA). Resuscitation was attempted in approximately 44% of these cases, with approximately 15.6% surviving to hospital admission. There is substantial subsequent mortality among those who survive to hospital, and survival to hospital discharge is about 5%. The cost to the NHS of OHCA management is estimated to be £320 m/year.

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Cardiac Arrest
Life Support
Paramedic
Resuscitation