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

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ClinicalTrials.gov Identifier: NCT03298880
Recruitment Status : Completed
First Posted : October 2, 2017
Last Update Posted : February 9, 2018
Sponsor:
Collaborator:
Royal Devon and Exeter NHS Foundation Trust
Information provided by (Responsible Party):
University of Exeter

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 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.

Condition or disease Intervention/treatment Phase
SVT Vagal Bradycardia Device: Supine VM VAD Device: Supine VAD manometer Other: Modified VM VAD Other: Modified VM Manonmeter Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Intervention Model: Sequential Assignment
Intervention Model Description: Four repeated measures in each participant in random order
Masking: None (Open Label)
Masking Description: Participants will not be able see manometer when using VAD Analysis of ECG traces will be blind to intervention as traces will be marked with a code, interventions carried out in random order and analysed in batches
Primary Purpose: Other
Official Title: Testing of a Valsalva Assist Device (VAD) to Assess Effects on Vagal Tone and Strain Pressures Achieved Compared to a Standard Manometer in Healthy Volunteers Performing Standard and Modified Valsalva Manoeuvres.
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : February 5, 2018
Actual Study Completion Date : February 5, 2018

Arm Intervention/treatment
Four VM's
Healthy volunteers undergo repeated VM's - Device: Supine VM VAD, Supine VAD manometer Modified VM VAD, Modified VM Manonmeter
Device: Supine VM VAD
Valsalva strain delivered using VAD
Other Name: Valsalva Assist Device supine

Device: Supine VAD manometer
supine Valsalva strain delivered using manometer
Other Name: Valsalva Assist Device

Other: Modified VM VAD
modified VM using VAD
Other Name: Standard (supine) position

Other: Modified VM Manonmeter
Postural modified position VM using manometer
Other Name: Modified VM position




Primary Outcome Measures :
  1. Assessing the effects on heart rate of a supine valsalva manoeuvre compared to the modified Valsalva manoeuvres in healthy volunteers. [ Time Frame: 3 minutes (4 repetitions of 45 seconds) ]
    The investigators will measure the longest RR length in mm during the 15 seconds during the manoeuvre and the 15 seconds afterwards on an 3 lead ECG trace. The investigators will measure pre strain heart rate using the 15 seconds of baseline heart rate before the maneouvre on the 3 lead ECG. Using an average of the RR length(mm). The heart rate in beats per minute will then be worked out using a calculation from the RR length. RR length (mm) x0.04 = RR in seconds. (10/RR in seconds)x60 = beats per minute


Secondary Outcome Measures :
  1. Testing of a Valsalva Assist Device (VAD) compared to the standard manometer to assess the peak sustained pressure in healthy volunteers. [ Time Frame: 1 minute (4 repetitions of 15 seconds) ]
    The investigators will measure the highest pressure achieved for more than a second using a manometer in mmHg

  2. Testing of a Valsalva Assist Device (VAD) compared to the standard manometer to assess the strain duration in healthy volunteers. [ Time Frame: 15 seconds (4 repetitions of 15 seconds) ]
    The investigators will measure the duration of the longest strain in seconds using a stopwatch.

  3. Assessing the effects on valsalva ratio of a supine valsalva manoeuvre compared to the modified Valsalva manoeuvres in healthy volunteers. [ Time Frame: 3 minutes ( 4 repetitions of 45 seconds) ]
    the valsalva ratio will be calculated to look at the difference between the VAD and the standard manometer. Measured using difference between pre and post manoeuvre heart rate.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03298880


Locations
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United Kingdom
Royal Devon & Exeter NHS FT
Exeter, Devon, United Kingdom, EX4 7DW
Sponsors and Collaborators
University of Exeter
Royal Devon and Exeter NHS Foundation Trust
Investigators
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Principal Investigator: Andrew Appelboam, MBBS Royal Devon & Exeter Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Exeter
ClinicalTrials.gov Identifier: NCT03298880    
Other Study ID Numbers: 1617/043
First Posted: October 2, 2017    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Exeter:
Valsalva manoeuvre
Vagal tone
Modified Valsalva
Valsalva Assist Device
Additional relevant MeSH terms:
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Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes