A Pilot Study of the Use of Oscillation and Lung Expansion (OLE) Therapy in Patients Hospitalized With COVID-19
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 6
- 试验地点
- 4
- 主要终点
- Hospital Length of Stay
研究概览
简要总结
A Pilot Study of the Use of Oscillation and Lung Expansion (OLE) Therapy in Patients Hospitalized with COVID-19
详细描述
This is a randomized prospective open-label cohort study in patients with COVID-19 to evaluate the impact of Oscillation and Lung Expansion (OLE) therapy using The MetaNeb® System on the hospital length of stay in patients hospitalized and receiving heated high-flow oxygen therapy for COVID-19 infection. The active treatment group will consist of patients who are treated OLE therapy while on heated high-flow oxygen therapy .
Results from subjects in the active treatment group will be compared to results from patients treated with standard care with no OLE therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Adult patient (> 18 years of age)
- •Tested positive or person under investigation (PUI) for COVID-19 infection
- •Currently require heated high-flow oxygen therapy to maintain SaO2 > 90 %
- •Signed informed consent (phone consent)
- •Heated high-flow oxygen initiated within the past 72 hours
排除标准
- •Serious medical condition that, in the investigator's judgment, precludes the patient's safe participation in the study
- •Pressure related risk for pneumothorax
- •Patient inability or unwillingness to tolerate OLE therapy
- •Staff unavailable or unable to deliver therapy
- •Current requirement for mechanical ventilation or expected requirement for mechanical ventilation within the next 12 hours
结局指标
主要结局
Hospital Length of Stay
时间窗: Time frame begins when the patient is first started on heated high-flow oxygen therapy and ends when they are ready for discharge from the hospital. Expected time is a a few days but not expected to exceed 3 weeks.
Number of days/hours the patient is in the hospital after initiation of high-flow oxygen therapy
次要结局
未报告次要终点