The Use of a Bidirectional Oxygenation Valve in the Management of Respiratory Failure Due to COVID-19 Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 6
- 主要终点
- Pulse oximetry level
研究概览
简要总结
This study will utilize a single center internal control study design. The objective of this study is to determine the feasibility and safety of a bidirectional oxygenation PEEP generating mouthpiece when combined with oxygen by non-rebreather face mask, compared to support by oxygen non-rebreather face mask alone.
详细描述
We have developed a simple and straightforward silicone rubber-made oral appliance that promotes positive expiratory airway pressures with the potential to enhance respiratory function while preventing and reversing atelectasis and hypoxia. The purpose of this study is to compare the use of our bidirectional oxygenation mouthpiece with conventional oxygen support versus conventional oxygen support of any Person Under Investigation for infection by the COVID-19 virus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Oxygen saturation <93%
- •Able to provide informed consent
- •Not currently requiring intubation
- •Receiving oxygen by face mask
排除标准
- •Unable or unwilling to provide informed consent, cognitive impairment
- •Rapidly decompensating status requiring urgent or emergent higher level of care
结局指标
主要结局
Pulse oximetry level
时间窗: Change from Baseline pulse oximetry level at 15 minutes post treatment
The primary endpoint for this feasibility study is pulse oximetry level after treatment with a Bidirectional Oxygenation Valve
次要结局
- Systemic carbon dioxide(Change from Baseline clinical measurements at 15 minutes post treatment)
- Respiratory rate(Change from Baseline clinical measurements at 15 minutes post treatment)
- Blood pressure(Change from Baseline clinical measurements at 15 minutes post treatment)
- Heart rate(Change from Baseline clinical measurements at 15 minutes post treatment)