Evaluation of the Valsalva Assist Device to treat SVT [EVADE SVT]

  • Research type

    Research Study

  • Full title

    Evaluation of Pre-hospital use of a Valsalva Assist Devise (VAD) in the Emergency treatment of supraventricular tachycardia (SVT). A stepped-wedge cluster randomised controlled trial [EVADE SVT]

  • IRAS ID

    287604

  • Contact name

    Andrew Appelboam

  • Contact email

    andy.appelboam@nhs.net

  • Sponsor organisation

    South Western Ambulance Service NHS foundation Trust

  • ISRCTN Number

    ISRCTN16145266

  • Duration of Study in the UK

    2 years, 6 months, 1 days

  • Research summary

    A common heart problem called Supraventricular tachycardia (SVT) can cause the heart to suddenly start beating very quickly, causing palpitations and making patients feel unwell. People with an episode of SVT are often seen by the ambulance service and paramedic guidelines recommend a simple, safe, physical treatment called the ‘Valsalva manoeuvre’ (VM) to get the heart beat back to normal.

    This involves a strain whilst blowing (like inflating a stiff balloon), normally done by blowing into an empty syringe. If the manoeuvre is successful, patients (who are usually otherwise well) feel immediately better and do not always need to be taken to hospital.

    Unfortunately, the VM often doesn't work and so most patients are currently taken to hospital and may need strong, unpleasant drugs to correct their heart beat. However, blowing into a simple, easy to use, safe and approved device, the Valsalva Assist Device (VAD), might help patients do a better VM and avoid emergency hospital admission. Patients, who have helped design and run this study, tell us they really value feeling better as soon as possible and avoiding hospital if not needed.

    In this study, we plan to introduce the device into normal ambulance service care, to see if this can reduce the number of SVT patients who are taken to hospital. Only patients who are treated with a VM will be included and only routine, anonymous data collected. It is just the way in which the VM strain is being done that will change; the rest of the patients' care will be as normal. However, we will tell patients about the study after they have been treated, including how to opt out of having their data used should they wish, and give them further information about their condition and an option to tell us how it affects them.

  • REC name

    South Central - Oxford C Research Ethics Committee

  • REC reference

    22/SC/0032

  • Date of REC Opinion

    11 Mar 2022

  • REC opinion

    Favourable Opinion