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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

Title: 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
Authors: Andrew Appelboam; Sarah Black; Victoria Jones; James King; Mark Dayer; Peter Chapman; Helen Harris; Andy Cole; Ben Jones; Obioha Ukoumunne; Neil Armstrong; Mike Smith; Annie Hawton; Emma Cockcroft; Siobhan Creanor; Lucy Davies; Matthew Adams; Nicholas Richards; Shelley Rhodes; David Willis; Martyn Morris; Adam Hill; Harry Brown; Mark Reilly; William Price; Annette Gillett; Phoebe Dawe; Alison Coppola; Ria Osborne; Natalie Scotney; Suzanne Boot; Tim Cranston; Ruth Hawker; Michela Cox; Beccy Summers; Yunli Ou; Leanne Bessell; Ludwig Holzer; Ross Clarkson; Charlotte Macey-Woolmer; Leigh Simpkins; Sarah-Jane Hill; Andy Waring; Will Kivell; Alice Foxen; Samuel Withams; Jade Barber; Tarin Payne; Thomas Boyling; Kristin Houlgate; Dane O'Reilly; Jamie Sprake; Dylan Evans; Daniel Titcombe; Gemma Abbott; Peter Caine; Ben Astley; Vince McKenzie-Plume; Jim Burn; Ashley Ingram; Paula Long; Joe Phipps; Lewis Hare; Kirsty Walker; Charlotte Copley; James Keat; Craig Chedzoy; Leah Mason; Rich Godfrey; Dale Jefferies; Nicole Morrison; Kirsty Carpenter; Steve Palmer; Tara Marchant; Sabrina Bolwell; Tracy Hoad; Stuart Stimson; Collette Young; Oscar Miller; Joe Meering; Ashley Watson; Katharine Laurenson; Lee Clarke; John Carrielies; Sharon Bowyer; Adam Blinman; Anna McCann; Carrie-Anne Durrant; Charlotte Blow; Chris Taplin; Marcus Goodwin; Damon Godfrey; Maree Holmes; Rhys Allsopp; Peter Willows; Katrina Scott; Sonia Wright-Stainton; Stacey Lawrence; Jacquiline Mullarney; Lewis Garrood; Tom Rutherford; Luke Slocombe; Alan Piper; Julia Ryder; Tom Driver; Hannah Barber; Joe Cartwright; Loxley Patterson; Chris Birch; Kelly Chappell; James Constable; Naomi Miller; Tara Rodda; Tim Taylor; Jason Trudgill; Russell Hoskin; Julie Legg; Toni Howell; Fergus Beeley; Zoe Flowerdew; Gary Rooney; Cassandra Day; Tamara Hoare; Dylan Carey; Lewis Murphy
Source: BMJ Open, Vol 13, Iss 6 (2023)
Publisher Information: BMJ Publishing Group
Publication Year: 2023
Collection: Directory of Open Access Journals: DOAJ Articles
Subject Terms: Medicine
Description: 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.
Document Type: article in journal/newspaper
Language: English
Relation: https://bmjopen.bmj.com/content/13/6/e073315.full; https://doaj.org/toc/2044-6055; https://doaj.org/article/9ba077145f604b38a7cc822cb0276100
DOI: 10.1136/bmjopen-2023-073315
Availability: https://doi.org/10.1136/bmjopen-2023-073315; https://doaj.org/article/9ba077145f604b38a7cc822cb0276100
Accession Number: edsbas.82504E6E
Database: BASE