Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Jun 8;13(6):e073315.
doi: 10.1136/bmjopen-2023-073315.

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

Andrew Appelboam  1   2 , Ria Osborne  3 , Obioha Ukoumunne  4 , Sarah Black  3 , Suzanne Boot  5 , Nicholas Richards  5 , Natalie Scotney  5 , Shelley Rhodes  6 , Tim Cranston  6 , Ruth Hawker  7 , Annette Gillett  8 , Ben Jones  6 , Annie Hawton  4   9 , Mark Dayer  10   11 , Siobhan Creanor  6 ; EVADE SVT Study Collaborators
Collaborators, Affiliations

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

Andrew Appelboam et al. BMJ Open. .

Abstract

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.

Keywords: ACCIDENT & EMERGENCY MEDICINE; Adult cardiology; Pacing & electrophysiology.

PubMed Disclaimer

Conflict of interest statement

Competing interests: AA, on behalf of the Royal Devon University Healthcare NHS Foundation Trust (RDUFT), introduced the concept of the Valsalva Assist Device to Meditech Systems Limited and advised on refinements to the device in light of initial volunteer studies. RDUFT has a royalty agreement on future sales of the device. Any money received can only be used for patient care or further research.

Figures

Figure 1
Figure 1
The ‘Valsa-Valve’ Valsalva Assist Device packaging and device details. CE, Conformité Européene; QTY, quantity; REF, reference number; RH, relative humidity; SWASFT, South Western Ambulance Service NHS Foundation Trust.
Figure 2
Figure 2
Scheme for the randomised stepped wedge introduction of the Valsalva Assist Device to the ambulance service.
See this image and copyright information in PMC

References

    1. Orejarena LA, Vidaillet H, DeStefano F, et al. . Paroxysmal supraventricular tachycardia in the general population. J Am Coll Cardiol 1998;31:150–7. 10.1016/s0735-1097(97)00422-1 - DOI - PubMed
    1. Wood KA, Drew BJ, Scheinman MM. Frequency of disabling symptoms in supraventricular tachycardia. Am J Cardiol 1997;79:145–9. 10.1016/s0002-9149(96)00701-1 - DOI - PubMed
    1. Smith G, McD Taylor D, Morgans A, et al. . Measuring the effectiveness of a revised clinical practice guideline for the pre-hospital management of supraventricular tachycardia. Emerg Med Australas 2015;27:22–8. 10.1111/1742-6723.12340 - DOI - PubMed
    1. JRCALC guidelines. 2023. Available: https://aace.org.uk/clinical-practice-guidelines/
    1. Resuscitation Council (UK) . Resuscitation Guidelines,. 2005. Available: http://www.resus.org.uk/pages/guide.htm

Publication types

Associated data

LinkOut - more resources