3D Printing of Positive Airway Pressure (PAP) Therapy Masks: a Single Site Pilot and Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- To pilot the feasibility of using 3D printing technology to develop customised masks for patients receiving PAP therapy. This will be assessed through the secondary outcome measures and the Medical Research Council Complex Intervention Framework
研究概览
简要总结
This study is a single site pilot and feasibility study. We propose that 3D printing could be used to create customised masks for patients requiring Positive Airway Pressure (PAP) therapy. We hypothesise that the use of this technology may result in; improved compliance with therapy, increased comfort, reduced side effects, increased quality of life and reduced healthcare costs.
详细描述
Stage 1:
10 health participants. subjects will be asked to attend for a mask fitting using off the shelf standard mask stock. They will then be trialed on PAP therapy (breathing machine) for 10 minutes. Mask leak, skin reactions and comfort scores will be assessed.
Subjects will then attend for 3D printing of a mask. Following the production of the 3D mask, repeat measurements with the 3d mask on PAP therapy will be taken.
If all healthy subjects complete the trial without any serious adverse events, then the second phase of the study with patients will commence.
Stage 2:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- 是
入选标准
- •Members of staff working at Royal Free London NHS Foundation Trust
排除标准
- •Staff with known sleep disordered breathing. Staff with suggestion of sleep disordered breathing on the STOP Bang and Epworth Sleepiness Score screening tools
- •Inclusion Criteria:
- •Patients will be recruited from the existing sleep and ventilation database at RFL. Patients with an established diagnosis of sleep disordered breathing with known interface concerns will be recruited. Patients who have been identified as having problematic interface concerns resulting in mask leak, poor mask fit, pressure ulcers and reduced effectiveness of PAP therapy
- •Exclusion Criteria:
- •Patients who are clinically unstable as assessed by a clinical member of the research team. Patients with evidence of active infection on clinical assessment. Patients who have dependent on their therapy for more than 16 hours in a 24 hour period. Patients with active pressure ulcers.
结局指标
主要结局
To pilot the feasibility of using 3D printing technology to develop customised masks for patients receiving PAP therapy. This will be assessed through the secondary outcome measures and the Medical Research Council Complex Intervention Framework
时间窗: 5 days
Acceptability of 3D printed customised PAP masks by patients and healthcare professionals
次要结局
- Comfort(5 days)
- Side effects(5 days)
- Mask leak(5 days)