Assessment of AnchorFast Guard Oral Endotracheal Tube Fastener on Patients Intubated With Oral Endotracheal Tubes With Subglottic Suction
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 6
- 主要终点
- Proportion of Participants on Which Test Product Allowed for Proper Placement of the Subglottic Suction Lumen
研究概览
简要总结
Assessment of AnchorFast Guard Oral Endotracheal Tube Fastener on Patients Intubated with Oral Endotracheal Tubes with Subglottic Suction
详细描述
Endotracheal intubation is the trans laryngeal placement of a tube into the trachea via the nose or mouth. Subglottic suctioning, during endotracheal tube securement, is important for mechanically-ventilated patients to allow for the clearance of secretions that may accumulate during intubation. This protocol examines an enhancement to the current AnchorFast Guard device in order for the device to hold a subglottic suctioning lumen in addition to the intubation 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
- Supportive Care
- 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 requires oral tracheal intubation
- •Has intact skin on application site
- •Is qualified to participate in the opinion of the Investigator including the requirement for endotracheal tube with subglottic suction
排除标准
- •Has an existing neck injury
- •Has protruding upper teeth, is without teeth or is unable to wear upper dentures
- •Has facial hair
- •Has clinically significant skin damage, condition or disease on the application site which may contraindicate participation
- •Has a known or stated allergy to adhesive bandages, or any of the product types being tested
- •Uses of topical drugs, lotions, creams or oils on the application site
- •Is participating in any clinical testing which may affect performance of this device
- •AnchorFast Guard Oral Endotracheal Tube Fastener does not fit subject's face
结局指标
主要结局
Proportion of Participants on Which Test Product Allowed for Proper Placement of the Subglottic Suction Lumen
时间窗: Typical wear time of endotracheal tube fastener up to one week
Assessed by the proportion of yes/no researcher responses
Proportion of Participants on Which the Subglottic Suction Lumen Was Easy to Place Into the Tract With the Tube Protection Sleeve
时间窗: Typical wear time of endotracheal tube fastener up to one week
Assessed by the proportion of researcher responses that equal agree (4) plus strongly agree (5) on a five point scale that includes strongly disagree (1) disagree (2) and no opinion (3)
Proportion of Participants on Which the Test Product Protected the Subglottic Suction Lumen
时间窗: Typical wear time of endotracheal tube fastener up to one week
Assessed by the proportion of yes/no researcher responses
Proportion of Participants on Which the Test Product Allowed for Effective Subglottic Suctioning
时间窗: Typical wear time of endotracheal tube fastener up to one week
Assessed by the proportion of yes/no researcher responses
Proportion of Participants on Which the Test Product Allowed the Subglottic Suction Lumen to Remain Within the Subglottic Suction Lumen Tract
时间窗: Typical wear time of endotracheal tube fastener up to one week
Assessed by the proportion of yes/no researcher responses
次要结局
未报告次要终点