Trial Outcomes & Findings for Testing of a Valsalva Assist Device (VAD) in Healthy Volunteers Performing a Valsalva Manoeuvre (NCT NCT03298880)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

75 participants

Primary outcome timeframe

3 minutes (4 repetitions of 45 seconds)

Results posted on

2021-06-10

Participant Flow

Participant milestones

Participant milestones
Measure	Four VM's Healthy volunteers undergo repeated VM's - Device: Supine VM VAD, Supine VAD manometer Modified VM VAD, Modified VM Manonmeter Supine VM VAD: Valsalva strain delivered using VAD Supine VAD manometer: supine Valsalva strain delivered using manometer Modified VM VAD: modified VM using VAD Modified VM Manonmeter: Postural modified position VM using manometer
Overall Study STARTED	75
Overall Study COMPLETED	75
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Four VM's n=75 Participants Healthy volunteers undergo repeated VM's - Device: Supine VM VAD, Supine VAD manometer Modified VM VAD, Modified VM Manonmeter Supine VM VAD: Valsalva strain delivered using VAD Supine VAD manometer: supine Valsalva strain delivered using manometer Modified VM VAD: modified VM using VAD Modified VM Manonmeter: Postural modified position VM using manometer
Age, Categorical <=18 years	0 Participants n=75 Participants
Age, Categorical Between 18 and 65 years	75 Participants n=75 Participants
Age, Categorical >=65 years	0 Participants n=75 Participants
Age, Continuous	26.19 years n=75 Participants
Sex: Female, Male Female	45 Participants n=75 Participants
Sex: Female, Male Male	30 Participants n=75 Participants
Region of Enrollment United Kingdom	75 participants n=75 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Mean Drop in Heart Rate Using the Modified VM n=75 Participants This measures the mean drop in heart rate before and after the modified valsalva manoeuvre using both the VAD and monometer	Mean Drop in Heart Rate of Supine VM n=75 Participants This measures the mean drop in heart rate before and after the supine valsalva manouevre using the both the VAD and monometer	Mean Drop in Heart Rate Using VAD n=75 Participants This measures the mean drop in heart rate before and after healthy participants undertook the modified and supine Valsalva manoeuvres while using the VAD	Mean Drop in Heart Rate From Using the Manometer n=75 Participants This measures the mean drop in heart rate before and after healthy participants undertook the modified and supine Valsalva manoeuvres while using the manometer
Assessing Heart Rate During the Supine and Modified VM and Assessing Heart Rate While Using the VAD and Manometer	33.6 beat per minute Interval 6.3 to 70.2	25.9 beat per minute Interval 5.4 to 61.2	28.7 beat per minute Interval 8.2 to 70.2	30.8 beat per minute Interval 5.4 to 61.2

SECONDARY outcome

Timeframe: 1 minute (4 repetitions of 15 seconds)

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.

Outcome measures

Outcome measures
Measure	Mean Drop in Heart Rate Using the Modified VM n=75 Participants This measures the mean drop in heart rate before and after the modified valsalva manoeuvre using both the VAD and monometer	Mean Drop in Heart Rate of Supine VM n=75 Participants This measures the mean drop in heart rate before and after the supine valsalva manouevre using the both the VAD and monometer	Mean Drop in Heart Rate Using VAD This measures the mean drop in heart rate before and after healthy participants undertook the modified and supine Valsalva manoeuvres while using the VAD	Mean Drop in Heart Rate From Using the Manometer This measures the mean drop in heart rate before and after healthy participants undertook the modified and supine Valsalva manoeuvres while using the manometer
Percentage of Participants Who Acheived a 15 Second Strain Duration During a VM Comparing a Valsalva Assist Device and a Standard Manometer	56 Participants	73 Participants	—	—

SECONDARY outcome

Timeframe: 15 seconds (4 repetitions of 15 seconds)

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

Outcome measures

Outcome measures
Measure	Mean Drop in Heart Rate Using the Modified VM n=75 Participants This measures the mean drop in heart rate before and after the modified valsalva manoeuvre using both the VAD and monometer	Mean Drop in Heart Rate of Supine VM n=75 Participants This measures the mean drop in heart rate before and after the supine valsalva manouevre using the both the VAD and monometer	Mean Drop in Heart Rate Using VAD This measures the mean drop in heart rate before and after healthy participants undertook the modified and supine Valsalva manoeuvres while using the VAD	Mean Drop in Heart Rate From Using the Manometer This measures the mean drop in heart rate before and after healthy participants undertook the modified and supine Valsalva manoeuvres while using the manometer
Peak Sustained Pressure Testing of a Valsalva Assist Device (VAD) Compared to the Standard Manometer	42.46 mean (mmHg) of peak pressures acheived Interval 30.0 to 50.0	39.96 mean (mmHg) of peak pressures acheived Interval 25.0 to 50.0	—	—

Adverse Events

Four VM's

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Four VM's n=75 participants at risk Healthy volunteers undergo repeated VM's - Device: Supine VM VAD, Supine VAD manometer Modified VM VAD, Modified VM Manonmeter Supine VM VAD: Valsalva strain delivered using VAD Supine VAD manometer: supine Valsalva strain delivered using manometer Modified VM VAD: modified VM using VAD Modified VM Manonmeter: Postural modified position VM using manometer
Nervous system disorders headache	22.7% 17/75 • 15 minutes as each patient was taking part this was a very low risk study

Additional Information

Dr Andrew Appelboam, Isabel FitzGerald

University of Exeter, Royal Devon and Exeter Hospital

Phone: 07515688294

Email: [email protected] ; [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place