Evaluation of the Valsalva Assist Device to Treat SVT
Launched by SOUTH WESTERN AMBULANCE SERVICE NHS FOUNDATION TRUST · May 1, 2018
Trial Information
Current as of August 25, 2025
Completed
Keywords
ClinConnect Summary
The investigators plan to conduct a pragmatic, randomised controlled trial of the use of the Valsalva Assist Device (VAD) versus standard care to treat SVT delivered by ambulance clinicians.
Ambulance clinicians within South West Ambulance Service Foundation Trust (SWASFT) will be invited to help deliver this study by becoming recruiting practitioners. All participating ambulance clinicians will have specific trial training including an update of SVT management, use of the VAD and GCP training as needed. It is estimated a two month ambulance clinician recruitment period would enable approx...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Adult patients (above 17years)
- • Presenting with SVT which the ambulance clinician identifies as being eligible for a vagal manoeuvre
- Exclusion Criteria:
- • Unable or unwilling to give informed verbal consent
- • Unstable condition (systolic blood pressure (BP) \< 90mmHg) \[Increased risk of feeling or actually fainting with a VM which causes a transient fall in BP as a normal physiological response\]
- • Atrial fibrillation or atrial flutter on ECG \[VM considered ineffective in these rhythms\]
- • Severe hypertension (systolic BP \>220mmHg or diastolic BP \>120mmHg) \[Risk of further increase in BP at end of VM - a normal physiological response\]
- • Contraindication or inability to perform a modified Valsalva manoeuvre in the opinion of the practitioner. This will include but not limited to: Aortic stenosis, recent myocardial infarction, glaucoma, retinopathy and inability to perform a Valsalva manoeuvre, to lie flat or have legs lifted. \[We will exclude all those that could conceivable come to any harm from performing a VM\]
- • Third trimester pregnancy \[Lying flat can cause fainting in late pregnancy\]
- • Prisoners
- • Previous inclusion in the study
About South Western Ambulance Service Nhs Foundation Trust
South Western Ambulance Service NHS Foundation Trust is a leading healthcare organization dedicated to providing high-quality emergency and urgent care services across the South West of England. As a clinical trial sponsor, the Trust emphasizes innovation and research to enhance patient outcomes and advance medical knowledge. With a commitment to safety and ethical standards, the Trust collaborates with a range of stakeholders, including healthcare professionals and academic institutions, to facilitate cutting-edge clinical research that addresses pressing healthcare challenges and improves service delivery within the community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Exeter, South West England, United Kingdom
Patients applied
Trial Officials
Andrew Appelboam, MBBS, FRCEM
Principal Investigator
Royal Devon and Exeter NHS Foundation Trust
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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