NCT03716713Unknown不适用
CeraShield™ Endotracheal Tube Feasibility Study
N8 Medical, LLC2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年11月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Incidence of Adverse Events
研究概览
简要总结
Single-arm, feasibility study to evaluate the Ceragenin Coated Endotracheal Tube (the CeraShield ETT) in adults who require intubation and are expected to be mechanically ventilated for ≥ 24 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Age of 18 years or older;
- •Patients requiring a 7.0mm, 7.5mm, 8.0mm or 8.5mm endotracheal tube;
- •Expected to be mechanically ventilated for ≥24 hours.
排除标准
- •Currently participating in another clinical trial which conflicts with this trial's design.
- •Patients with a pre-existing respiratory infection, i.e., pneumonia.
- •Patients with pulmonary contusions.
- •Patients with cystic fibrosis.
- •Patients demonstrating symptoms of bronchiectasis.
- •Patients demonstrating symptoms of severe or massive hemoptysis. Severe or massive hemoptysis defined as greater than 500 ml of blood per day, or greater than 200 ml in six hours.
- •Patients who have been intubated within the last 30 days requiring reintubation.
- •Women of child-bearing potential who have not undergone a pregnancy test will be excluded from the study.
- •Patient is pregnant.
研究组 & 干预措施
CeraShield Endotracheal Tube
Experimental
Subjects who are expected to require mechanical ventilation for 24 hours or longer will be intubated with the CeraShield ETT.
干预措施: CeraShield Endotracheal Tube (Device)
结局指标
主要结局
Incidence of Adverse Events
时间窗: Up to 30 days post enrollment or hospital discharge, whichever comes first
The safety of the CeraShield ETT tube will be assessed by reviewing adverse events in all patients enrolled in the study
次要结局
- Positive ETT colonization(10 days post intubation)
- Positive QEA(10 days post intubation)
研究者
研究点 (2)
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