RT Journal Article
SR Electronic
T1 Evaluation of the prehospital use of a Valsalva assist device in the emergency treatment of supraventricular tachycardia (EVADE SVT): study protocol for a stepped wedge cluster randomised controlled trial
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e073315
DO 10.1136/bmjopen-2023-073315
VO 13
IS 6
A1 Appelboam, Andrew
A1 Osborne, Ria
A1 Ukoumunne, Obioha
A1 Black, Sarah
A1 Boot, Suzanne
A1 Richards, Nicholas
A1 Scotney, Natalie
A1 Rhodes, Shelley
A1 Cranston, Tim
A1 Hawker, Ruth
A1 Gillett, Annette
A1 Jones, Ben
A1 Hawton, Annie
A1 Dayer, Mark
A1 Creanor, Siobhan
A1 
YR 2023
UL http://bmjopen.bmj.com/content/13/6/e073315.abstract
AB Introduction Patients with episodes of supraventricular tachycardia (SVT), a common heart arrhythmia, are often attended by ambulance services. International guidelines advocate treatment with the Valsalva manoeuvre (VM), but this simple physical treatment has a low success rate, with most patients requiring conveyance to hospital. The Valsalva Assist Device (VAD) is a simple device that might help practitioners and patients perform a more effective VM and reduce the need for patients to be taken to hospital.Methods and analysis This stepped wedge cluster randomised controlled trial, conducted within a UK ambulance service, compares the current standard VM with a VAD-delivered VM in stable adult patients presenting to the ambulance service with SVT. The primary outcome is conveyance to hospital; secondary outcomes measures include cardioversion rates, duration of ambulance care and number of subsequent episodes of SVT requiring ambulance service care. We plan to recruit approximately 800 patients, to have 90% power to detect an absolute reduction in conveyance rate of 10% (from 90% to 80%) between the standard VM (control) and VAD-delivered VM (intervention). Such a reduction in conveyance would benefit patients, the ambulance service and receiving emergency departments. It is estimated potential savings would pay for devices for the entire ambulance trust within 7 months.Ethics and dissemination The study has been approved by the Oxford Research Ethics Committee (reference 22/SC/0032). Dissemination will be through peer-reviewed journal publication, presentation at national and international conferences and by the Arrhythmia Alliance, a patient support charity.Trial registration number ISRCTN16145266.