Loading search results
EVADE
Evaluation of Pre-hospital Use of a Valsalva Assist Devise (VAD) in the Emergency Treatment of Supraventricular Tachycardia (SVT). A Randomised Controlled Feasibility Trial [EVADE]
Sponsor study identifier
interventional
34
1 country
1
Study Start
July 1, 2018
Actual (reported)Primary Completion
December 31, 2018
Actual (reported)Study Completion
December 31, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 10, 2018
Actual (reported)May 2, 2018
Actual (reported)July 1, 2018
Actual (reported)December 31, 2018
Actual (reported)December 31, 2018
Actual (reported)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)
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)
Intervention is the use of Valsalva Assist Device (VAD) to deliver the Valsalva strain
Intervention is the use of Standard technique to deliver Valsalva strain eg blowing on empty syringe
The Valsalva strain will be produced using Standard Care techniques
Use of Valsalva Assist Device (VAD) to generate VM
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
29 Selected Ambulance Stations
Exeter, South West England, United Kingdom
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.
Andrew Appelboam, MBBS, FRCEM
Royal Devon and Exeter NHS Foundation Trust
34 participants (actual enrollment reported by the registry).
First Submitted
April 10, 2018
First Posted
May 2, 2018
Study Start
July 1, 2018
Contact the study team to confirm eligibility.
Primary Completion
December 31, 2018
Actual (reported)Study Completion
December 31, 2018
Actual (reported)Last Updated
November 14, 2019
Record last verified: 2019-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: