Trials Sponsors Conditions Drugs Pricing

Conditions

SVT Vagal Bradycardia

Keywords

Valsalva manoeuvreVagal toneModified ValsalvaValsalva 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 VADDevice: Supine VAD manometerOther: Modified VM VADOther: Modified VM Manonmeter

Interventions

Supine VM VADDevice

Valsalva strain delivered using VAD

Also known as: Valsalva Assist Device supine

Four VM's

Supine VAD manometerDevice

supine Valsalva strain delivered using manometer

Also known as: Valsalva Assist Device

Eligibility Criteria

Age18 Years - 60 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (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

Sponsors & Collaborators

Royal Devon and Exeter NHS Foundation Trust
Othercollaborator
University of Exeter
Otherlead

Study Sites (1)

Royal Devon & Exeter NHS FT

Exeter, Devon, EX4 7DW, United Kingdom

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: 30504456DERIVED

MeSH Terms

Interventions

Supine PositionPatient Positioning

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

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

Study Officials

Andrew Appelboam, MBBS
Royal Devon and Exeter NHS Foundation Trust
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

75 participants (actual enrollment reported by the registry).

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

Study Record Dates

First Submitted

September 8, 2017

First Posted

October 2, 2017

Study Start

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Four VM's

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Four VM's

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations