Sonia Byers

Pre-hospital Assessment of the Role of Adrenaline: Measuring the Effectiveness of Drug administration In Cardiac arrest (PARAMEDIC-2): Trial protocol

Despite its use since the 1960s, the safety or effectiveness of adrenaline as a treatment for cardiac arrest has never been comprehensively evaluated in a clinical trial. Although most studies have found that adrenaline increases the chance of return of spontaneous circulation for short periods, many studies found harmful effects on the brain and raise concern that adrenaline may reduce overall survival and/or good neurological outcome. The PARAMEDIC-2 trial seeks to determine if adrenaline is safe and effective in out-of-hospital cardiac arrest. This is a pragmatic, individually randomised, double blind, controlled trial with a parallel economic evaluation. Participants will be eligible if they are in cardiac arrest in the out-of-hospital environment and advanced life support is initiated. Exclusions are cardiac arrest as a result of anaphylaxis or life threatening asthma, and patient known or appearing to be under 16 or pregnant. 8000 participants treated by 5 UK ambulance services will be randomised between December 2014 and August 2017 to adrenaline (intervention) or placebo (control) through opening pre-randomised drug packs. Clinical outcomes are survival to 30 days (primary outcome), hospital discharge, 3, 6 and 12 months, health related quality of life, and neurological and cognitive outcomes (secondary outcomes). Trial registration (ISRCTN73485024).

Post-admission outcomes of participants in the PARAMEDIC trial : a cluster randomised trial of mechanical or manual chest compressions

BACKGROUND The PARAMEDIC cluster randomised trial evaluated the LUCAS mechanical chest compression device, and did not find evidence that use of mechanical chest compression led to an improvement in survival at 30 days. This paper reports patient outcomes from admission to hospital to 12 months after randomisation. METHODS Information about hospital length of stay and intensive care management was obtained through linkage with Hospital Episode Statistics and the Intensive Care National Audit and Research Centre. Patients surviving to hospital discharge were approached to complete questionnaires (SF-12v2, EQ-5D, MMSE, HADS and PTSD-CL) at 90days and 12 months. The study is registered with Current Controlled Trials, number ISRCTN08233942. RESULTS 377 patients in the LUCAS arm and 658 patients in the manual chest compression were admitted to hospital. Hospital and intensive care length of stay were similar. Long term follow-up assessments were limited by poor response rates (53.7% at 3 months and 55.6% at 12 months). Follow-up rates were lower in those with worse neurological function. Among respondents, long term health related quality of life outcomes and emotional well-being was similar between groups. Cognitive function, measured by MMSE, was marginally lower in the LUCAS arm mean 26.9 (SD 3.7) compared to control mean 28.0 (SD 2.3), adjusted mean difference -1.5 (95% CI -2.6 to -0.4). CONCLUSION There were no clinically important differences identified in outcomes at long term follow-up between those allocated to the mechanical chest compression compared to those receiving manual chest compression.

The challenges of conducting prehospital research: successes and lessons learnt from the Head Injury Transportation Straight to Neurosurgery (HITS-NS) trial

Head Injury Transportation Straight to Neurosurgery was a cluster randomised trial studying suspected severe head injury treatment pathways conducted in the North East Ambulance Service NHS Foundation Trust and North West Ambulance Service NHS Trust between January 2012 and March 2013. This was the worlds first large scale trial of any trauma bypass and was conducted as a feasibility study. This short report will describe some of the lessons learnt during this ground breaking and complex trial.

Bypassing nearest hospital for more distant neuroscience care in head-injured adults with suspected traumatic brain injury: findings of the head injury transportation straight to neurosurgery (HITS-NS) pilot cluster randomised trial

Objective Reconfiguration of trauma services, with direct transport of patients with traumatic brain injury (TBI) to specialist neuroscience centres (SNCs)—bypassing non-specialist acute hospitals (NSAHs), could improve outcomes. However, delays in stabilisation of airway, breathing and circulation (ABC) may worsen outcomes when compared with selective secondary transfer from nearest NSAH to SNC. We conducted a pilot cluster randomised controlled trial to determine the feasibility and plausibility of bypassing suspected patients with TBI —directly into SNCs—producing a measurable effect. Setting Two English Ambulance Services. Participants 74 clusters (ambulance stations) were randomised within pairs after matching for important characteristics. Clusters enrolled head-injured adults—injured nearest to an NSAH—with internationally accepted TBI risk factors and stable ABC. We excluded participants attended by Helicopter Emergency Medical Services or who were injured more than 1 hour by road from nearest SNC. Interventions Intervention cluster participants were transported directly to an SNC bypassing nearest NSAH; control cluster participants were transported to nearest NSAH with selective secondary transfer to SNC. Outcomes Trial recruitment rate (target n=700 per annum) and percentage with TBI on CT scan (target 80%) were the primary feasibility outcomes. 30-day mortality, 6-month Extended Glasgow Outcome Scale and quality of life were secondary outcomes. Results 56 ambulance station clusters recruited 293 patients in 12 months. The trial arms were similar in terms of age, conscious level and injury severity. Less than 25% of recruited patients had TBI on CT (n=70) with 7% (n=20) requiring neurosurgery. Complete case analysis showed similar 30-day mortality in the two trial arms (control=8.8 (2.7–14.0)% vs intervention=9.4(2.3–14.0)%). Conclusion Bypassing patients with suspected TBI to SNCs gives an overtriage (false positive) ratio of 13:1 for neurosurgical intervention and 4:1 for TBI. A measurable effect from a full trial of early neuroscience care following bypass is therefore unlikely. Trial registration number ISRCTN68087745.

A COMPARISON OF MANUAL AND MECHANICAL CARDIOPULMONARY RESUSCITATION ON THE MOVE USING A MANIKIN: SINGLE-PERSON AND TWO-PERSON EMERGENCY MEDICAL SERVICE CREWS

Background Delivery of good quality cardiopulmonary resuscitation (CPR) is essential for survival from cardiac arrest but manual CPR has its limitations, especially in the pre-hospital environment and situations which demand transportation. Our aim was to examine the effect that transporting a patient during Advanced Life Support (ALS) has on the quality of CPR being provided. In the same simulated pre-hospital scenario we directly compared manual (standard) CPR (SCPR) and mechanical CPR (MCPR), as well as comparing both against the 2010 European Resuscitation Council guidelines. The quality of CPR provided by one and two person crews was also compared. Methods Ten experienced paramedics volunteered to take part in four pre-hospital observational manikin CPR scenarios each. The mechanical CPR device chosen was the LUCASTM2. Data were captured electronically using QCPRTM with the core values being minute-by-minute mean compression rate and depth, as well as variations within, hands off ratios and the average time to CPR commencement. Results A marked reduction in the rate, depth and percentage of correct compressions was noted when the paramedics started to move the patient. When compared against the 2010 ERC guidelines, SCPR was more variable than MCPR and not delivered in a way that conforms to the guidelines. MCPR was consistent and conformed to the guidelines. There was significant time required for a single paramedic to start CPR with a mechanical device. Conclusion In the pre-hospital setting having to transport a patient during ALS can have a negative impact on the quality of CPR being provided. The quality of CPR is closer to that currently recommended when provided by a mechanical device rather than manually, but two persons would be required for rapid deployment of the device. This could suggest a potential role for pre-hospital MCPR even in the absence of recommendation for routine use.