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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Assessing Heart Rate During the Supine and Modified VM and Assessing Heart Rate While Using the VAD and Manometer
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Assessing Heart Rate During the Supine and Modified VM and Assessing Heart Rate While Using the VAD and Manometer
时间窗: 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
次要结局
- 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))