02 The evaluation of the pre-hospital use of a valsalva assist device in the emergency treatment of supraventricular tachycardia [EVADE SVT] study – surviving a cyber-attack

<h3>Background</h3> The modified Valsalva Manoeuvre (VM) is a recommended first line treatment of supraventricular tachycardia (SVT) used by emergency medical services globally. In practice, effective manoeuvres may be difficult to perform, and most patients require conveyance to hospital. A simple Valsalva Assist Device (VAD) was evaluated to establish whether it could improve pre-hospital treatment and conveyance rates. <h3>Methods</h3> We conducted a stepped wedge cluster randomised trial of the VAD versus standard VM to treat SVT within South Western Ambulance Service NHS Foundation Trust (SWASFT). We used routinely collected electronic clinical data and opt out consent. Sample size target was 800 patients, across 80 ambulance station clusters, over 5 activation phases (4 months each). Totalling 20 months recruitment, to detect a 10%-point difference between VAD and standard VM conveyance rates. <h3>Results</h3> In July 2023, during the fourth period of recruitment, SWASFTs electronic record system was affected by a cyber-attack. This resulted in the encryption of 19 million clinical records, quarantine of active records, and a return to hand-written clinical notes, lasting 3 months. Successful completion of the trial required labour-intensive hand-searching of 240,000 paper clinical records to identify potential recruits. Final recruitment, despite the challenges, was 865 participants who had undergone a SWASFT delivered VM. <h3>Conclusion</h3> Ambulance services see and treat a large number of suspected SVT patients with a VM. Routine electronic clinical data systems can be used to efficiently identify participants and collect trial data but are at risk from cyber-attack. Contingency plans should be considered in such trials. The main study results and implications for practice will be published in due course. <b>This study is funded by the NIHR Research for Patient Benefit Programme (NIHR202185). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.</b>