Status:
COMPLETED
Testing of a Valsalva Assist Device (VAD) in Healthy Volunteers Performing a Valsalva Manoeuvre
Lead Sponsor:
University of Exeter
Collaborating Sponsors:
Royal Devon and Exeter NHS Foundation Trust
Conditions:
SVT
Vagal Bradycardia
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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 del...
Detailed Description
The aim of this study is to evaluate the performance of a novel Valsalva assist device (VAD) in healthy volunteer and to confirm the physiological effects of a modified VM. Specific Objectives: To m...
Eligibility Criteria
Inclusion
- Adult Volunteers between 18 and 60 years old from University of Exeter or RD\&E Hospital staff
- Sinus rhythm on initial ECG
- Self-reported good health
Exclusion
- Any regular medication other than the oral contraceptive
- Previous cardiovascular or respiratory disease
- Any contraindication to performing a VM strain. (Eg. Known aortic stenosis, recent myocardial infarction, glaucoma, retinopathy)
- Pregnancy
- Any ECG abnormality
- Any contra-indication to postural modification (any reason the participant can't lie flat and have both legs lifted to 45 degrees, eg prosthetic hip
- Inability or refusal to give written consent to take part
- Observations of heart rate, oxygen saturations, respiratory rate or blood pressure outside the normal range. Specifically blood pressure less than 100 systolic
- Caffeinated drinks within 6 hours prior to testing
- The use of stimulant drugs or alcohol within 24 hours prior to testing
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 5 2018
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT03298880
Start Date
November 1 2017
End Date
February 5 2018
Last Update
June 10 2021
Active Locations (1)
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1
Royal Devon & Exeter NHS FT
Exeter, Devon, United Kingdom, EX4 7DW