ACTRN12623000466640尚未招募未知
Safety and Tolerability of 3-Dimensional Printing Assisted Non Invasive Ventilation Masks in Children with Obstructive and Restrictive Airway Disease
Perth Children's Hospital0 个研究点目标入组 10 人开始时间: 2023年5月5日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- Years 至 18 Years（—）
- 性别
- All
入选标准
- •1)Inability to tolerate conventional masks due to: Fit, leak, hypoxemia, and pressure sores.
- •2)Ongoing need for NIV masks based on respiratory physician assessment, qualitatively based on the comfort, leak, pressure areas, as well as quantitative data from the NIV machine regarding the compliance and AHI. A formal polysomnography may be requested if further quantification of the need for NIV is required.
- •3)Respiratory physician assessment to ensure that non-compliance is due to inability to tolerate NIV masks secondary to poor fit, measured via the Mask Fit & Comfort questionnaire, and the objective downloadable data where they are non compliant with its use.
- •4)Exhausted the 2 commercially available mask options at Perth Children’s Hospital.
- •5)Consent from caregivers and or mature minors
排除标准
- •1)Patients over the age of 18 years old
- •2)Patients not needing NIV masks
- •3)Patients for whom commercially available NIV masks fit well
- •4)Allergic skin reaction to commercially available NIV masks (medical grade silicone)
研究者
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