SVTNCT03298880
Testing of a Valsalva Assist Device (VAD) in Healthy Volunteers Performing a Valsalva Manoeuvre
A study testing Supine VM VAD, Supine VAD manometer and Modified VM VAD in people with SVT and Vagal Bradycardia, run by University of Exeter at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- SVT, Vagal Bradycardia
- What is being tested?
- Supine VM VAD, Supine VAD manometer and Modified VM VAD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2017to 5 Feb 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Devon & Exeter NHS FT
Exeter, Devon, EX4 7DW
About this study
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.
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.
Read the 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)
- Conditions
- SVT, Vagal Bradycardia
- Being tested
- Supine VM VAD, Supine VAD manometer, Modified VM VAD, Modified VM Manonmeter
- Keywords
- Valsalva manoeuvre, Vagal tone, Modified Valsalva, Valsalva Assist Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supine VM VADDevice
Also called Valsalva Assist Device supine
Valsalva strain delivered using VAD
Supine VAD manometerDevice
Also called Valsalva Assist Device
supine Valsalva strain delivered using manometer
Modified VM VADOther
Also called Standard (supine) position
modified VM using VAD
Modified VM ManonmeterOther
Also called Modified VM position
Postural modified position VM using manometer
| Study group | Role | What they receive |
|---|---|---|
| Four VM's | Other | Healthy volunteers undergo repeated VM's - Device: Supine VM VAD, Supine VAD manometer Modified VM VAD, Modified VM Manonmeter Receives: Device: Supine VM VAD; Device: Supine VAD manometer; Other: Modified VM VAD; Other: Modified VM Manonmeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing Heart Rate During the Supine and Modified VM and Assessing Heart Rate While Using the VAD and Manometer
Assessing the effects on heart rate of a supine valsalva manoeuvre compared to the modified Valsalva manoeuvres in healthy volunteers.The investigators will measure the longest RR (length between each r wave) 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. These arms are combined so as to make the data easier to understand. The higher the number the better the outcome. maximum score is minimum score is 25.9 with maximum 33.6
Measured: 3 minutes (4 repetitions of 45 seconds)
Secondary outcomes (2)
Percentage of Participants Who Acheived a 15 Second Strain Duration During a VM Comparing a Valsalva Assist Device and a Standard Manometer
The investigators measured the time each Valsalva manoeuvre managed to keep to a 15-second drain if they managed 15 seconds at a pressure of 35-45mmHg this would count as an achieved strain.
Measured: 1 minute (4 repetitions of 15 seconds)
Peak Sustained Pressure Testing of a Valsalva Assist Device (VAD) Compared to the Standard Manometer
The investigators will measure the highest pressure achieved for more than a second using a manometer in mmHg and compare these done with the VAD and the manometer
Measured: 15 seconds (4 repetitions of 15 seconds)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study start1 Nov 2017
- Primary completion5 Feb 2018
- Study completion5 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SVTStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Four repeated measures in each participant in random order
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Devon and Exeter NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Andrew Appelboam, MBBS, Principal investigator, Royal Devon and Exeter NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03298880
- Sponsor's protocol ID
- 1617/043
- Status last verified
- Jun 2021
- First submitted
- 8 Sep 2017
- Last updated
- 10 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30504456
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03298880
- Acronym / sponsor ID
- 1617/043
- Conditions
- SVT, Vagal Bradycardia
- Keywords
- Valsalva manoeuvre, Vagal tone, Modified Valsalva, Valsalva Assist Device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- Royal Devon and Exeter NHS Foundation Trust
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 5 Feb 2018 (actual)
- Study completion
- 5 Feb 2018 (actual)
- First posted
- 2 Oct 2017 (actual)
- Results
- Posted 10 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Four repeated measures in each participant in random order
| Arm | Type | Receives |
|---|---|---|
| Four VM's | Other | Device: Supine VM VAD, Device: Supine VAD manometer, Other: Modified VM VAD, Other: Modified VM ManonmeterHealthy volunteers undergo repeated VM's - Device: Supine VM VAD, Supine VAD manometer Modified VM VAD, Modified VM Manonmeter |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supine VM VADAlso: Valsalva Assist Device supineValsalva strain delivered using VAD | Device | Four VM's |
| Supine VAD manometerAlso: Valsalva Assist Devicesupine Valsalva strain delivered using manometer | Device | Four VM's |
| Modified VM VADAlso: Standard (supine) positionmodified VM using VAD | Other | Four VM's |
| Modified VM ManonmeterAlso: Modified VM positionPostural modified position VM using manometer | Other | Four VM's |
Primary outcome
Assessing Heart Rate During the Supine and Modified VM and Assessing Heart Rate While Using the VAD and Manometer
Time frame: 3 minutes (4 repetitions of 45 seconds)
Assessing the effects on heart rate of a supine valsalva manoeuvre compared to the modified Valsalva manoeuvres in healthy volunteers.The investigators will measure the longest RR (length between each r wave) 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. These arms are combined so as to make the data easier to understand. The higher the number the better the outcome. maximum score is minimum score is 25.9 with maximum 33.6
2 secondary outcomes
Percentage of Participants Who Acheived a 15 Second Strain Duration During a VM Comparing a Valsalva Assist Device and a Standard Manometer
Time frame: 1 minute (4 repetitions of 15 seconds)
Peak Sustained Pressure Testing of a Valsalva Assist Device (VAD) Compared to the Standard Manometer
Time frame: 15 seconds (4 repetitions of 15 seconds)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30504456FitzGerald 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Appelboam, MBBS principal investigator
Royal Devon and Exeter NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supine VM VAD, Supine VAD manometer and Modified VM VAD in people with SVT and Vagal Bradycardia, run by University of Exeter at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing Heart Rate During the Supine and Modified VM and Assessing Heart Rate While Using the VAD and Manometer (time frame: 3 minutes (4 repetitions of 45 seconds)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03298880, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2021.