Comparison of the Oxymask and Oxy2mask on Supplemental Oxygen Delivery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Required Flowrate
研究概览
简要总结
The purpose of this study is to determine if the performance of a newly released oxygen mask is the same, better, or worse than previous mask version. We will measure the flow rate necessary to maintain the same oxygen saturation in adult patients using each mask.
详细描述
Southmedic, Inc. has received approval to distribute a newly designed oxygen mask. The current design has been studied and the FiO2 delivered reported to be inconsistent. The purpose of this study is to determine if the performance is the same, better, or worse than current mask. We can evaluate performance by determining Liter flow required to maintain oxygen saturations that are within limits described in NM CDH oxygen protocol. We will measure the flow rate necessary to maintain the same saturation in adult patients using both the OxyMask and Oxy2Mask. The Oxymask has a flow device inside the mask that has been revised since implementation. The mask itself is otherwise unchanged. We intend to determine if the same amount of flow results in the same outcome.
This study will include adult patients that require supplemental oxygen and we do not believe the patients will report a difference between each mask. The only variance in care is mask version used, the oxygen protocol will remain the same.
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
- •Participants have oxygen device and are being titrated per NM CDH oxygen protocol (maintained between 90%-96%; or 88% - 92% if CO2 retainer)
- •Participants to have period of stability; 2 hours at same liter flow on open design mask, 5-15 lpm
- •All adult patients (> 18 years old) in med surge units (bed tower)
- •Post-op patients requiring oxygen on Post-op Day
- •Patients currently on >5 LPM via nasal cannula, clinician can recommend the change to OxyMask. If remains on >5 LPM via OxyMask, patient can be included.
- •Oxygen protocol will be followed per standards of care.
排除标准
- •Patients receiving home oxygen therapy who do not require additional oxygen during hospital stay.
- •Patients with a history of Bleomycin therapy.
- •Patients with a history of Paraquat poisoning
- •Patients that are pregnant
研究组 & 干预措施
Oxy2mask
Change oxymask to oxy2mask
干预措施: Oxy2mask (Device)
结局指标
主要结局
Required Flowrate
时间窗: 4 hours
Flow (LPM) required to maintain target oxygen saturation
次要结局
未报告次要终点
研究者
Patti DeJuilio
Director Respiratory Care and Diagnostic Services
Northwestern Medicine