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

Study Description

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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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 measure and compare peak strain pressure and duration produced using the device compared to a standard manometer in supine and modified postures

To evaluate whether there is a difference in vagal tone (drop in heart rate) in healthy volunteers performing a VM using the VAD versus manometer.

To evaluate whether there is a difference in vagal tone (drop in heart rate) in healthy volunteers performing a modified VM versus a standard supine VM using the VAD.

To evaluate whether there is a difference in vagal tone (drop in heart rate) in healthy volunteers performing a modified VM versus a standard supine VM using a manometer.

The investigators will conduct a single centre repeated measures observational study of use of the device to generate a Valsalva strain in a sample of healthy adult volunteers from the University of Exeter or RD&E Hospital staff. All participants will be screened for eligibility and undergo informed written consent prior to participation. If participants fail screening due to abnormal clinical readings or vital signs, the chief investigator will review them, any urgent abnormalities (very unlikely) would be reviewed by the chief investigator or delegated emergency department doctor as soon as they are discovered. Depending on the severity, if treatment is required urgently then they will be treated in the emergency department. Otherwise, they will be referred back to their GP. Potential participants will be given written information about the study at least 24 hours prior to recruitment and interested individuals invited to attend screening, recruitment and testing.

Potential participants will be invited to express an interest in taking part by responding to the trial poster. These posters will be displayed in the medical student common rooms ED department notice board. The potential participant contacts the researcher leading the practical aspects of the trial by phone or email. Respondents will be asked how they would like to receive further information (post, email, and phone) and offered an appointment at the Clinical Research Facility (CRF) for screening and written consent if eligible, at their convenience but at least 24 hours after receiving the information sheet. Given the simple, safe and quick nature of the interventions, participants will be given the choice to take part after written consent or to return on another date, whichever they would prefer, to ensure minimal visits whilst giving participants further time to consider taking part should they wish.

The VM is an extremely safe, physiological manoeuvre which is used in everyday life (eg straining at stool) and has been used in trial conditions and clinical practice many thousands of times with no serious adverse events. The investigators will exclude participants who could conceivably be at any risk of harm from performing a VM or from the use of the device.

The screening will include 12 lead ECG and physical examination including observations of heart rate, oxygen saturations, respiratory rate and blood pressure. Any participants with any detected abnormalities, whether they are excluded from participation or not, will be informed and referred to their primary care physician as appropriate. All testing will be conducted in the clinical research facility (CRF) of the Royal Devon & Exeter Hospital, according to a strict trial protocol.

Test Valsalva Manoeuvres:

Participants will undergo a total of 4 VMs of the following 4 variations in random order, stratified by method of strain generation to ensure balance between the order of manometer and device use:

Supine VM using a manometer. Supine Valsalva strain using a manometer visible to the participant with a target of 40mmHg for 15 seconds
Supine VM using the device. Supine Valsalva strain using the device connected to manometer invisible to the participant but visible to a researcher for 15 seconds
Modified VM using a manometer. Semi-recumbent (at 45 degrees) Valsalva stain using a manometer visible to the participant with a target of 40mmHg for 15 seconds followed by supine positioning and passive 45-degree leg lift immediately at the end of the strain for a further 15 seconds (the modified VM)
Modified VM using the device. Semi-recumbent (at 45 degrees) Valsalva strain using the device connected to manometer invisible to the participant but visible to a researcher for 15 seconds followed by supine positioning and passive 45-degree leg lift immediately at the end of the strain for a further 15 seconds (the modified VM)

Study Design

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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

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures :

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 :

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
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.
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.

Eligibility Criteria

Information from the National Library of Medicine

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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

Contacts and Locations

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

FitzGerald I, Ewings P, Lang I, Appelboam A. Testing of a novel Valsalva Assist Device with supine and modified positions in healthy volunteers. Emerg Med J. 2019 Jan;36(1):27-31. doi: 10.1136/emermed-2018-208004. Epub 2018 Dec 1.

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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

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