Evaluation of the Valsalva Assist Device to Treat SVT

NCT03514628 | Completed

• 1 other identifier: 238130
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The Valsalva Assist Device (VAD) is a simple hand held device, designed to assist in the physical treatment of a common, fast heart rhythm disorder called supraventricular tachycardia (SVT). This treatment, called the Valsalva manoeuvre (VM), is a safe, physical technique involving a forced exhalation against resistance (like that required to blow up a balloon). This causes a reflex slowing of the heart and can correct attacks of SVT (cardioversion). It is an internationally recommended initial treatment but previously has had a low success rate (5-27%) and patients often have to be taken to hospital for drug treatment. Recent hospital research has demonstrated that a VM carried out using a certain level of strain pressure(40mmHg) measured with a blood pressure manometer, combined with a simple postural modification (the modified VM) gives a far better chance of success (43%) and avoids the need for drug treatment. More practical methods of generating this strain such as blowing on an empty syringe have been used but are unreliable. The Valsalva Assist Device (VAD) has been designed to provide the correct resistance and is packaged with instructions for the modified VM. Attacks of SVT frequently occur without warning in otherwise healthy people. Patients are often initially seen by ambulance staff and so the use of the VAD therefore represents an opportunity to provide ambulance clinicians with instructions for the modified VM and a means to deliver the correct strain in one, easy to use device. The investigators plan to test use of the device in patients with an attack of SVT and attended by paramedics or other pre-hospital practitioner, compared to current recommended practice. This project will provide important feasibility and recruitment data for a definitive trial, assessing the performance of the VAD on SVT cardioversion and conveyance (transfer to hospital) rates.

Conditions

SVT; Vagal Bradycardia; Emergencies

Keywords

Valsalva Manoeuvre; SVT; Valsalva Assist Device

Outcome Measures

Primary Outcomes (2)

• Clinician recruitment

  A key measures for this pilot project will be the rate of ambulance clinician recruitment.

  At study completion (after an 8 month recruitment period)

• Participant recruitment

  The number of participants recruited to the trial

  At study completion (after an 8 month recruitment period)

Secondary Outcomes (3)

• Cardioversion rates

  At study completion (after an 8 month recruitment period)

• Conveyance rates

  At study completion (after an 8 month recruitment period)

• Completeness of data

  At study completion (after an 8 month recruitment period)

Study Arms (2)

Valsalva Assist Device (VAD)

EXPERIMENTAL

Intervention is the use of Valsalva Assist Device (VAD) to deliver the Valsalva strain

Device: Valsalva Assist Device (VAD)

Standard Care

ACTIVE COMPARATOR

Intervention is the use of Standard technique to deliver Valsalva strain eg blowing on empty syringe

Other: Standard Care

Interventions

Standard Care OTHER

The Valsalva strain will be produced using Standard Care techniques

Standard Care

Valsalva Assist Device (VAD) DEVICE

Use of Valsalva Assist Device (VAD) to generate VM

Valsalva Assist Device (VAD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (above 17years)
• Presenting with SVT which the ambulance clinician identifies as being eligible for a vagal manoeuvre

You may not qualify if:

• 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

Sponsors & Collaborators

• South Western Ambulance Service NHS Foundation Trust: lead
• Royal Devon and Exeter NHS Foundation Trust: collaborator
• Academic Health Science Centres: collaborator

Study Sites (1)

29 Selected Ambulance Stations

Exeter, South West England, United Kingdom

Location

Related Publications (1)

• Appelboam A, Green J, Ewings P, Black S; EVADE study SWASFT collaborators. Evaluation of pre-hospital use of a valsalva assist device in the emergency treatment of supraventricular tachycardia [EVADE]: a randomised controlled feasibility trial. Pilot Feasibility Stud. 2020 May 25;6:74. doi: 10.1186/s40814-020-00616-y. eCollection 2020.

  PMID: 32509319 DERIVED

MeSH Terms

Conditions

Emergencies

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Andrew Appelboam, MBBS, FRCEM

  Royal Devon and Exeter NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Data analysis and determination of primary outcome will be done blind to allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 randomisation to VAD or standard care

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: May 2, 2018
• Study Start: July 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: November 14, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)