The Effect of Mask Design on Transcutaneous Carbon Dioxide in Healthy Volunteers: A Pilot Clinical Investigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in transcutaneous carbon dioxide (CO2)
研究概览
简要总结
The goal of this randomized cross-over study is to investigate whether the design of non-invasive ventilation (NIV) mask impacts transcutaneous CO2 in healthy volunteers on NIV therapy. The main questions it aims to answer are:
- To assess if mask design impacts transcutaneous CO2 in healthy volunteers.
- To assess if mask design impacts tidal volume or respiratory rate in healthy volunteers.
Participants will attend three study visits:
- Visit 1. Participants will be fitted to use non-invasive ventilation briefly to acclimatize them to using the therapy.
- Visit 2. Participants will receive NIV with one of two masks. They will be asked to breathe through their mouth or through their nose, with a break from NIV in between the two sessions of NIV.
- Visit 3. Participants will receive NIV with the other mask, repeating Visit 2.
详细描述
The study compares breathing with two different NIV masks, the interventional mask and the conventional NIV mask. Participants will be monitored by transcutaneous carbon dioxide, electrical impedance tomography (EIT) and heart rate, oxygen and respiratory rate monitors.
Participants will attend three study visits:
- Visit 1. Participants will be fitted to use NIV briefly to acclimatize them to using the therapy and ensure the two study masks fit. Participants that fit the masks and tolerate NIV well will be invited to attend two further visits.
- Visit 2. Participants will be randomized as to which order they receive the masks and which order they conduct mouth breathing and nose breathing. Baseline readings of normal unsupported breathing will be taken prior to going on NIV. Participants will the receive NIV with one of two masks for ten minutes, and will be instructed to either breathe with their mouth open or their mouth closed. There will then be a break from NIV of at least ten minutes until baseline values of respiratory parameters have returned. Then there will be a second ten minute period of NIV when the participant will be instructed to breathe through the other way - mouth-closed or mouth-open. One NIV therapy has been removed the participant will remain attached to the study monitoring equipment until respiratory parameters have returned to normal.
- Visit 3 is a repeat of Visit 2 with the other study mask. The study is then complete.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 years or over
- •Able to give informed consent
排除标准
- •Unable to tolerate non-invasive ventilation (NIV)
- •Unable to adequately fit an NIV mask
- •Claustrophobia while using NIV
- •Reported pregnancy
- •Symptoms of cold or flu (included COVID-19) in previous twenty four hours
- •Pneumothorax or history of previous pneumothorax
研究组 & 干预措施
Arm 1
NIV using Mask A, with mouth-open
干预措施: Non-invasive ventilation (NIV) (Device)
Arm 2
NIV using Mask A, with mouth-closed
干预措施: Non-invasive ventilation (NIV) (Device)
Arm 3
NIV using Mask B, with mouth-open
干预措施: Non-invasive ventilation (NIV) (Device)
Arm 4
NIV using Mask B, with mouth-closed
干预措施: Non-invasive ventilation (NIV) (Device)
结局指标
主要结局
Change in transcutaneous carbon dioxide (CO2)
时间窗: Continuous assessment collected during baseline normal breathing and from the start to the finish of each NIV session.
To assess if mask design can reduce transcutaneous CO2, in healthy volunteers.
次要结局
- Change in respiratory rate(Continuous assessment collected during baseline normal breathing and from the start to the finish of each NIV session.)
- Change in tidal volume(Continuous assessment collected during baseline normal breathing and from the start to the finish of each NIV session.)