Pilot Study Assessing the Feasibility and Safety of the Airway Exchange Broncholaryngoscope (AEBLScope) During Routine Tracheostomy Tube Exchanges
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Feasibility - First-pass success rate of tracheostomy tube exchange using the AEBLScope
研究概览
简要总结
This pilot study evaluates the safety and feasibility of a novel airway exchange broncholaryngoscope (AEBLScope) during routine tracheostomy tube exchanges in chronically tracheostomy-dependent adult outpatients.
详细描述
The AEBLScope is a modified disposable bronchoscope designed to allow for simultaneous visualization during airway tube exchanges. This prospective, single-arm pilot study will assess the safety, feasibility, and effectiveness of the AEBLScope in low-risk airway tube exchanges.
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 ≥18 years
- •Chronically (>1 month) tracheostomy-dependent outpatients
- •Currently not requiring ventilatory or supplemental oxygen support
- •Have undergone at least one prior tracheostomy tube exchange
- •Scheduled for routine in-office tracheostomy tube exchange
- •Able to provide informed consent
排除标准
- •Active respiratory infection
- •Patients with airway tubes having an inner diameter less than 6.0 mm
- •Patients with preexisting pulmonary conditions, including chronic obstructive pulmonary disease (COPD), restrictive lung disease, untreated pneumonia, or acute respiratory distress syndrome (ARDS)
- •Patients who are tracheostomy-dependent but cannot be orotracheally intubated.
- •Patients unable to provide informed consent and who have no legally authorized representative.
研究组 & 干预措施
Chronic Tracheostomy Tube-Dependent Patients
All participants will be be chronically tracheostomy-tube dependent and undergo routine, in-office tracheostomy tube exchanges using the AEBLScope device.
干预措施: Airway-Exchange Broncholaryngoscope (AEBLScope) (Device)
结局指标
主要结局
Feasibility - First-pass success rate of tracheostomy tube exchange using the AEBLScope
时间窗: During procedure, at time of intervention
First-pass success defined as successful tracheostomy tube placement on initial attempt using the AEBLScope without need for repeat attempt or alternative instrumentation.
次要结局
- Feasibility - Procedure duration(During procedure, at time of intervention)
- Safety - Procedural complications(During procedure, at time of intervention)
研究者
Karla O'Dell
Associate Professor of Otolaryngology - Head and Neck Surgery
University of Southern California