Feasibility Study of a Mask Adhesive in Patients Treated With NIV in an Institutional Setting
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Medical Adhesive-Related Skin Injury (MARSI)
研究概览
简要总结
To reduce interface leak and aerosol spread, Philips has developed an accessory to non-invasive ventilation(NIV) masks to be used with the Philips AF531 and the PerformaTrak mask on respiratory failure patients. For the purposes of capturing initial mask leak and safety data, this trial will enroll patients treated with NIV in an institutional setting (i.e., sleep lab).
详细描述
The Mask Adhesive will serve as an accessory to the AF531/PerformaTrak masks with the intention to reduce patient leak while a patient is receiving therapy. This accessory is a double-sided adhesive; with one side applied directly to the patient's skin and the other side connected to the mask cushion. Each adhesive is only to be applied to a patient once. The AF531/Performatrak mask can be removed from the adhesive and then re-applied, as necessary. For example, if the patient needs to remove the mask to eat or take medicine, the mask is removed from the patient and the adhesive will stay on the patient's face
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults patients age 18 to 85 (inclusive)
- •Adult patients treated with NIV
- •Able to read, write, and speak English
- •Able to provide written informed consent
- •Willing to have facial hair removed for adhesive placement (if required)
排除标准
- •Pre-existing allergy to tape or adhesive;
- •Blisters, open skin or pre-existing skin condition that may impact the ability to support removal of the mask adhesive without tearing the skin
- •pregnant (for females of childbearing age);
- •Individuals sentenced to such an institution under a criminal or civil statute,
- •Individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing
结局指标
主要结局
Medical Adhesive-Related Skin Injury (MARSI)
时间窗: Up to 5 business days
Percentage of patients who have severe and extreme skin irritation that persists for ≥ 30 min after mask adhesive removal (score of ≥ 3 on a 5-point grading system).
Clinician Ease of Use
时间窗: Initial Impressions at Baseline and Overall Impressions at Study Completion (After at least two mask applications)
Clinician-perceived mask adhesive ease-of-use as measured by a 0-10 Likert Scale at baseline (initial impressions) and study completion (overall impressions) Specifically, the item, "How would you rate the ease of application of the adhesive to the mask?" (On a 0 to 10 scale, with 0=Extremely Difficult and 10=Extremely Easy)
次要结局
- Leak Change(Up to 5 business days)