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

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.

Study Overview

• Status: Completed
• Conditions: SVT; Vagal Bradycardia
• Intervention / Treatment: Device: Supine VM VAD; Device: Supine VAD manometer; Other: Modified VM VAD; Other: Modified VM Manonmeter

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:

1. Supine VM using a manometer. Supine Valsalva strain using a manometer visible to the participant with a target of 40mmHg for 15 seconds
2. 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
3. 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)
4. 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 Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Devon
    • Exeter, Devon, United Kingdom, EX4 7DW
      • Royal Devon & Exeter NHS FT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: 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 Names: Valsalva Assist Device supine; Device: Supine VAD manometer; supine Valsalva strain delivered using manometer; Other Names: Valsalva Assist Device; Other: Modified VM VAD; modified VM using VAD; Other Names: Standard (supine) position; Other: Modified VM Manonmeter; Postural modified position VM using manometer; Other Names: Modified VM position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 minutes (4 repetitions of 45 seconds)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	15 seconds (4 repetitions of 15 seconds)

Collaborators and Investigators

• Sponsor: University of Exeter
• Collaborators: Royal Devon and Exeter NHS Foundation Trust
• Investigators: Principal Investigator: Andrew Appelboam, MBBS, Royal Devon & Exeter Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2017
• Primary Completion (ACTUAL): February 5, 2018
• Study Completion (ACTUAL): February 5, 2018

Study Registration Dates

• First Submitted: September 8, 2017
• First Submitted That Met QC Criteria: September 26, 2017
• First Posted (ACTUAL): October 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 10, 2021
• Last Update Submitted That Met QC Criteria: June 9, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Vagal tone; Valsalva Assist Device; Valsalva manoeuvre; Modified Valsalva
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Bradycardia
• Other Study ID Numbers: 1617/043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No