AirFLO2 Treatment for Hypoxia and/or Tachypnea in Patients With COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Oxygenation as Measured by P:F Ratio (PaO2:FiO2)
研究概览
简要总结
The study is an unblinded, randomized, controlled trial for use of the AirFlO2 device for patients admitted to Duke Hospital with COVID-19 and tachypnea (RR >20 breaths/min) and/or hypoxia (Oxygen saturation <94% on room air or requiring supplemental oxygen at baseline).
详细描述
The aim of the study is to determine whether the use of the AirFLO2 device can improve hypoxia as measured by change between partial pressure of arterial oxygen to fraction of inspired oxygen- P:F ratio (PaO2:FiO2) and repeat P:F ratio between 1 to 6 hours after using the device.
This is an unblinded, randomized, controlled trial for use of the AirFLO2 device for patients admitted to Duke Hospital with COVID-19 and tachypnea (RR >20 breaths/min) and/or hypoxia (Oxygen saturation <94% on room air or requiring supplemental oxygen at baseline).
Groups will be analyzed by intention to treat. Per-protocol analyses will also be performed. Descriptive statistics will be reported for the overall subject population, and for the two groups.
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
- •Adults ≥18 years of age with confirmed COVID-19 infection
- •Patient must be able to complete consent and hold mask
- •Baseline room air oxygen saturation <94% or new supplemental oxygen requirement at presentation or patient on supplemental oxygen at baseline and requiring up-titration of oxygen setting
- •Patient in negative pressure room
- •Patient must have access to an internet-connected device
排除标准
- •Tracheostomy
- •History of pneumothorax or known bullous lung disease
- •Recent cataract surgery
- •Patient receiving NIV (Noninvasive Ventilation) or HFNC (High Flow Nasal Cannula)
- •Patient receiving mechanical ventilation
结局指标
主要结局
Oxygenation as Measured by P:F Ratio (PaO2:FiO2)
时间窗: Baseline, 24 hours, 48 hours
A higher P:F ratio value indicates better oxygenation. Range 20 to 500.
次要结局
- Change in Participant Cough Symptoms as Measured by the Leicester Cough Questionnaire (LCQ)(baseline to up to six hours for device intervention participants; baseline to hospital discharge (up to 30 days) for all patients)
- Number of Participants Transferred to the ICU(baseline to end of hospitalization, (discharge from hospital or death, 1 - 30 days range))
- Number of Participants Who Survived to Discharge(baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days expected range))
- Hospitalization Length of Stay in Days(baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range))
- Subject Dyspnea Symptoms(baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range))
- Change in Participant Respiratory Symptoms as Measured by the St George Respiratory Questionnaire (SGRC)(baseline to up to six hours for device intervention participants; baseline to hospital discharge (up to 30 days) for all patients)
- Number of Participants Transferred to High Flow Nasal Cannula (HFNC), Non-invasive Ventilation (NIV), or Invasive Ventilation(baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range))
- Number of Participants Requiring Intubation(baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range))