N/A
N=75
Testing of a Valsalva Assist Device (VAD) in Healthy Volunteers Performing a Valsalva Manoeuvre
SVT · Vagal Bradycardia
Bottom Line
View on ClinicalTrials.gov: NCT03298880 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Assessing Heart Rate During the Supine and Modified VM and Assessing Heart Rate While Using the VAD and Manometer — 33.6; 25.9; 28.7; 30.8 beat per minute — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Supine VM VAD (Device); Supine VAD manometer (Device); Modified VM VAD (Other); Modified VM Manonmeter (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Exeter
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessing Heart Rate During the Supine and Modified VM and Assessing Heart Rate While Using the VAD and Manometer |
33.6; 25.9; 28.7; 30.8 | <0.001 sig |
| SECONDARY Percentage of Participants Who Acheived a 15 Second Strain Duration During a VM Comparing a Valsalva Assist Device and a Standard Manometer |
56; 73 | — |
| SECONDARY Peak Sustained Pressure Testing of a Valsalva Assist Device (VAD) Compared to the Standard Manometer |
42.46; 39.96 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03298880). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.