UNDER the Nose vs. Over the Nose Face Mask to Prevent Facial PRESSURE Ulcers During Face Mask-noninvasive Ventilation for Acute Hypercapnic Respiratory Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Change of the incidence of facial pressure ulcers in the experimental arm compared to the control arm, within the first 3 days after NIV initiation.
研究概览
简要总结
Noninvasive ventilation (NIV) is essential to treat acute hypercapnic respiratory failure. However, facial pressure ulcers appearing during facemask-delivered noninvasive ventilation are a source of NIV failure by interface intolerance.
A Philips facemask (model : AF541 SE Oro-Nasal mask) has the particularity to display two options for its positioning : a usually used "over-the-nose" positioning or an "under-the-nose" positioning that is supposed to reduce the incidence of facial pressure ulcers while keeping in the same time the qualities of a standard facemask.
The goal of this controlled randomized trial is to test the hypothesis that the "under-the-nose" positioning actually reduces the incidence of facial pressure ulcers, compared to the usually used "over-the-nose" positioning.
Results of this trial should lead to the proposition of a new interface strategy to prevent facial pressure ulcers and therefore to improve the tolerance of NIV via the use of facemasks displaying an "under-the-nose" positioning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Acute hypercapnic respiratory failure
- •Initiation of NIV
- •Estimated cumulative time of NIV upper than 12 hours for the first 48 hours of hospitalization
排除标准
- •Contraindication for NIV (respiratory arrest, impossibility to fit the mask)
- •Intubated patient
- •Patient with a tracheostomy
- •Post-extubation respiratory failure
- •Patient exhibiting facial ulcers or skin lesions located at the insertion points of the mask before its hospitalization
- •Person declining NIV
- •Pregnancy
- •Dying person
结局指标
主要结局
Change of the incidence of facial pressure ulcers in the experimental arm compared to the control arm, within the first 3 days after NIV initiation.
时间窗: 3 days after NIV initiation
The primary endpoint is the development of a facial pressure ulcer within the first 3 days after NIV initiation
次要结局
- Change of the severity of facial pressure ulcers in the experimental arm, compared to the control arm(7 days after NIV initiation)
- Change of the patient comfort in the experimental arm, compared to the control arm(24 hours after NIV initiation)
- Change of the delay for facial pressure ulcers to appear in the experimental arm, compared to the control arm(7 days after NIV initiation)
- Change of the incidence of mask changes related to interface intolerance in the experimental arm, compared to the control arm(7 days after NIV initiation)
- Change of the incidence of NIV failure in the experimental arm, compared to the control arm(7 days after NIV initiation)