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
- 2
- 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
研究组 & 干预措施
OLE Therapy with The MetaNeb® System
Subjects in the active treatment group will receive OLE therapy with The MetaNeb® System following the labeled instructions for the device.
干预措施: MetaNeb® System (Device)
Control Group
The airway clearance regimen for subjects in the control group will be collected from the medical record.This information will be retrospectively collected from patients treated with standard care with no OLE therapy. Subjects in the control group will be identified from the population of patients previously admitted to the two study sites with COVID-19 infection who required invasive mechanical ventilation but were not treated with OLE therapy.
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