Assessment of AnchorFast Guard Subglottic ET (Endotracheal) Tube
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 4
- 主要终点
- Usability of Study Product
研究概览
简要总结
This study is designed to assess the acceptability and usability of a new Endotracheal Tube (ET) holding device for an orally intubated patient.
详细描述
This is a multiple site prospective assessment of the study product in ICU settings. The study is comprised of each intubated subject wearing one study product until the device either needs to be changed or is no longer required by the subject. The study product is designed to hold a standard or subglottic ET tube and help reduce the potential for occlusion (blockage) of the tube.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Is 18 years of age or older and require oral tracheal intubation with subglottic ET tube size 6.0-8.0mm
- •Requires the use of a bite block per the hospital's standard of care
- •Has intact skin on and around application site, including cheeks and lips
- •Oral cavity is free of open sores, ulcers, wounds, and lesions
- •Subject or Legal Authorized representative (LAR) able to provide informed consent for the study
- •Is qualified to participate in the opinion of the Investigator, or designee
排除标准
- •Has actual or perceived loose teeth, is without teeth, or is unable to wear upper dentures
- •Has facial hair that interferes with the adhesion of the skin barrier pads
- •Has a clinically significant skin disease or condition, or damaged skin on the application site, such as psoriasis, eczema, atopic dermatitis, active cancer, sores, sunburns, scars, moles
- •Has a medical condition, surgery or a procedure that prevents the proper application of the device, including placement of the neck strap.
- •Has a known or stated allergy to adhesives
- •Currently is participating in any clinical study which may affect the performance of the device
研究组 & 干预措施
New oral endotracheal tube holder
Single Study Product Arm
干预措施: New oral endotracheal tube holder (Device)
结局指标
主要结局
Usability of Study Product
时间窗: At application and product removal (maximum 29 days of patient wearing product)
The usability of the study product at application and at removal.
Overall Acceptability With Study Product
时间窗: At product removal (maximum 29 days of patient wearing product)
The overall acceptability relating to general experience with the study product during use will be rated with a 5-point Likert scale ranging from 1=Very Unacceptable to 5=Very Acceptable
次要结局
未报告次要终点