Evaluate the Impact of Noninvasive (NIV) With Expiratory Washout on Respiratory Rate of Patients With Acute Hypercapnic Respiratory Failure. A Prospective, Randomized Cross Over Pilot Investigation.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Change in respiratory rate
研究概览
简要总结
This study will determine if NIV using the Vela investigational mask with expiratory washout of the upper airway more effectively reduces respiratory rate in acute patients with hypercapnic respiratory failure. Patients admitted to hospital with acute respiratory failure (ARF) will be assessed for hypercapnic ARF by normal hospital protocols. Patients requiring noninvasive ventilation (NIV) will be set up on NIV as prescribed per standard of care. Enrollment onto the investigation will occur after the patient has been allowed to stabilize on NIV . Patients that meet the inclusion/exclusion criteria will be approached for consent. Investigation participants will receive two masks in random order;
- NIV for one hour with the investigational mask (Vela)
- NIV for one hour with the standard mask (Nivairo).
Participants will have their physiological respiratory parameters recorded.
详细描述
This is a simple study. Patients who are already on noninvasive ventilation (NIV) for acute respiratory failure will be approached for the study within the first 24 hours on NIV therapy.
The study will be conducted as described above. After the study patients will be able to choose which mask they continue their NIV on. They will continue NIV as part of their normal hospital care.
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)
盲法说明
NIV masks can not be masked during the treatments. Only the analysis will be masked.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have type II acute respiratory failure (ARF) and have been prescribed NIV
- •Arterial blood gas (ABG) Partial pressure of arterial carbon dioxide greater or equal to 6.0 kilopascals (45 millimeters of mercury)
- •Arterial blood gas acidity greater or equal to 7.35 prior to bilevel commencement
- •On NIV for 24 hours or less
- •Negative Covid-19 test
- •Are 18 years or older
排除标准
- •Contraindicated for NIV
- •On NIV in Emergency Department/ ward for more than 24 hours, within the last 48 hours
- •NIV is likely to fail and/or intubation be required, at the doctor's discretion
- •CPAP or bilevel pressure of 25 centimeters of water or more is required
- •Unable to tolerate NIV for the duration of the investigation
- •Do not fit the investigational mask or the standard mask
- •Pregnancy (tested under standard care)
- •Unable to understand the consent process
结局指标
主要结局
Change in respiratory rate
时间窗: 1 hour
The change in patient's respiratory rate over the 1 hour of the study arm
次要结局
未报告次要终点