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Testing of a Valsalva Assist Device (VAD) in Healthy Volunteers Performing a Valsalva Manoeuvre

NCT03298880 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2021-06-10

Study results available
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Summary

A prototype for a Valsalva Assist Device (VAD), which provides resistance to exhalation, has been developed and is ready for testing in healthy volunteers. There is a need to ensure the device can deliver the required strain and evaluate the physiological response (lowered heart rate) when used to deliver a Valsalva manoeuvre (VM) with and without postural modification.

Conditions

  • SVT
  • Vagal Bradycardia

Interventions

DEVICE

Supine VM VAD

Valsalva strain delivered using VAD

DEVICE

Supine VAD manometer

supine Valsalva strain delivered using manometer

OTHER

Modified VM VAD

modified VM using VAD

OTHER

Modified VM Manonmeter

Postural modified position VM using manometer

Sponsors & Collaborators

  • Royal Devon and Exeter NHS Foundation Trust

    collaborator OTHER

  • University of Exeter

    lead OTHER

Principal Investigators

  • Andrew Appelboam, MBBS · Royal Devon and Exeter NHS Foundation Trust

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2018-02-05
Completion
2018-02-05

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03298880 on ClinicalTrials.gov