A Novel Proportional Open Ventilation (POV) Device and Its Efficacy in Managing Acute Respiratory Failure in COVID-19 Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Life2000® Compared to HFNC (AIRVO)
研究概览
简要总结
To evaluate the use of Life2000® Ventilator, a novel proportional open ventilation system in critical care use of acute onset of respiratory failure (ARF) and mild to moderate forms of acute respiratory distress syndrome (ARDS) in COVID-19 patients and its ability to provide effective ventilatory benefits and or delay patients from progressing to more aggressive forms of invasive mechanical ventilation (IMV).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Patients who meet all of the following inclusion criteria and no
排除标准
- •will be included in the study:
- •A diagnosed or suspected COVID-19 patient requiring non-invasive ventilatory support and admitted to hospital
- •PaO2/FiO2 ≤ 300 (corrected for altitude)
- •RR ≤ 30/min during early use of oxygen
- •Adults of 18 years and older
- •Provision of written informed consent to participate in study by subject or legal representative.
- •Exclusion Criteria:
- •Patients who meet one or more of the following exclusion criteria will not be eligible for the study:
- •Patients under the age of 18
- •Patients who are not diagnosed or suspected of having an acute COVID-19 illness
- •Patients who do not require non-invasive ventilatory interventions, PaO2/FiO2 > 300 (corrected for altitude) and tolerating supplemental oxygen with SpO2 saturations ≥ 92%.
- •Patients who require immediate IMV upon admission or have a RR > 30/min on early oxygen intervention.
- •Thoracoabdominal desynchrony and paradoxical breathing at admission
- •Patients in immediate need of or on vasopressors upon ICU admission
- •Patients or legal representatives who are unwilling or unable to provide written consent.
研究组 & 干预措施
Life2000® Ventilator
Subjects in the active treatment group will receive ventilatory support with Life2000® Ventilator following the labeled instructions for the device.
干预措施: Life2000® Ventilator (Device)
Control Group
Subjects in the control group will be identified from the population of patients previously admitted to the study site with COVID-19 infection who required non-invasive oxygen therapy with HFNC but were not treated with NIV therapy. Subject data will be collected retrospectively from the medical record.
结局指标
主要结局
Life2000® Compared to HFNC (AIRVO)
时间窗: Time frame measured will include date that patient is admitted to hospital until date patient is discharged from hospital or death occurs with an anticipated 30 day time period, but shall not exceed 90 day time period.
Compared to HFNC (AIRVO), does the Life2000® Ventilator provide clinically relevant ventilatory support to COVID-19 patients with mild to moderate ARF or ARDS to prevent IMV.
次要结局
- PEEP level(Time frame measured will include date that patient is admitted to hospital until date patient is discharged from hospital or death occurs with an anticipated 30 day time period, but shall not exceed 90 day time period.)