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

NCT03298880 | Completed Results

• 1 other identifier: 1617/043
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

SVT; Vagal Bradycardia

Keywords

Valsalva manoeuvre; Vagal tone; Modified Valsalva; Valsalva Assist Device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percentage of Participants Who Acheived a 15 Second Strain Duration During a VM Comparing a Valsalva Assist Device and a Standard Manometer

  1 minute (4 repetitions of 15 seconds)

• Peak Sustained Pressure Testing of a Valsalva Assist Device (VAD) Compared to the Standard Manometer

  15 seconds (4 repetitions of 15 seconds)

Study Arms (1)

Four VM's

OTHER

Healthy volunteers undergo repeated VM's - Device: Supine VM VAD, Supine VAD manometer Modified VM VAD, Modified VM Manonmeter

Device: Supine VM VAD; Device: Supine VAD manometer; Other: Modified VM VAD; Other: Modified VM Manonmeter

Interventions

Supine VM VAD DEVICE

Valsalva strain delivered using VAD

Also known as: Valsalva Assist Device supine

Four VM's

Supine VAD manometer DEVICE

supine Valsalva strain delivered using manometer

Also known as: Valsalva Assist Device

Four VM's

Modified VM VAD OTHER

modified VM using VAD

Also known as: Standard (supine) position

Four VM's

Modified VM Manonmeter OTHER

Postural modified position VM using manometer

Also known as: Modified VM position

Four VM's

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Exeter: lead
• Royal Devon and Exeter NHS Foundation Trust: collaborator

Study Sites (1)

Royal Devon & Exeter NHS FT

Exeter, Devon, EX4 7DW, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 30504456 DERIVED

MeSH Terms

Interventions

Supine Position; Patient Positioning

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr Andrew Appelboam, Isabel FitzGerald
• Organization: University of Exeter, Royal Devon and Exeter Hospital

andy.appelboam@nhs.net ; if223@exeter.ac.uk

07515688294

Study Officials

• Andrew Appelboam, MBBS

  Royal Devon and Exeter NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Four repeated measures in each participant in random order

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: October 2, 2017
• Study Start: November 1, 2017
• Primary Completion: February 5, 2018
• Study Completion: February 5, 2018
• Last Updated: June 10, 2021
• Results First Posted: June 10, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)