NCT06236542尚未招募不适用
NextGen Tracheostomy Toolkit: Integrating Augmented and Virtual Reality With Robotics to Improve Tracheostomy Care
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 632
- 试验地点
- 4
- 主要终点
- Number of Successful first-time tracheostomy tube changes
研究概览
简要总结
The goal of this clinical trial is to test the NextGen Tracheostomy Toolkit in people who have a tracheostomy. The main questions it aims to answer are:
- What is the number of atraumatic tracheostomy suctionings before and after the use of automated robotic suctioning device divided by the total number of tracheostomy suctionings across arms experimental group 1 vs. control group?
- What is the number of atraumatic tracheostomy suctionings before and after the use of Nextgen Tracheostomy Toolkit divided by the total number of tracheostomy suctionings across arms experimental group 3 vs. control group?
- What is the number of successful first-time tracheostomy tube change attempts before and after the use of mixed reality tracheostomy tube change device divided by the total number of tracheostomy tube changes across arms experimental group 2 vs. control group?
- What is the number of successful first-time tracheostomy tube change attempts before and after the use of Nextgen Tracheostomy Toolkit divided by the total number of tracheostomy tube changes across arms experimental group 3 vs. control group? Participants will be randomly divided into 4 groups and assigned different interventions.
- Experimental group 1 will receive suctionings using automated robotic suctioning device.
- Experimental group 2 will receive tracheostomy tube changes using mixed reality tracheostomy tube changing system.
- Experimental group 3 will receive Nextgen Tracheostomy Toolkit that includes suctionings using automated robotic suctioning device and tracheostomy tube changes using mixed reality tracheostomy tube changing system.
- Control group will receive usual tracheostomy care Researchers will compare the four groups to see the effect of Nextgen tracheostomy toolkit and its components on the number of atraumatic tracheostomy suctionings and number of successful first-time tracheostomy tube changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Because blinding of participants and investigators is not practical, all groups will be aware of their respective treatment protocols, which will be considered in the analysis and interpretation of outcomes.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adult patients 18 years or older
- •those who received a tracheostomy during their hospital stay
- •those who were admitted to the hospital with a tracheostomy
排除标准
- 未提供
结局指标
主要结局
Number of Successful first-time tracheostomy tube changes
时间窗: An average of 6 weeks
successful first-time tracheostomy tube change attempts before and after the use of mixed reality tracheostomy tube change device; from the time of receiving a tracheostomy tube until discharge or tracheostomy decannulation.
Percent of Successful Atraumatic suctionings
时间窗: An average of 6 weeks
successful first-time tracheostomy tube change attempt, will be calculated by measuring the number of successful first-time tracheostomy tube change attempts over the total number of tracheostomy tube change attempts; from the time of receiving a tracheostomy tube until discharge or tracheostomy decannulation.
次要结局
- Occurrence of Tracheostomy tube dislodgments(During procedure up to 6 weeks)
- Occurrence of Airway Obstruction(An average of 6 weeks)
- Occurrence of False tract(During procedure)
- Patient/family acceptability(Immediately after procedure)
- Equitable delivery of care as assessed by summary of demographic factors(Immediately after procedure)
- Intensive care unit length of stay (LOS)(An average of 6 weeks)
- Occurrence of airway bleeding complications(During tracheostomy suctionings)
- Occurrence of Ventilator-associated pneumonia(An average of 6 weeks)
- Patient/family satisfaction(Immediately after procedure)
- Duration of mechanical ventilation(Approximately 2 weeks)
- Tracheostomy duration(An average of 6 weeks)
- Discomfort as assessed by a Visual Analog Pain Scale(During tracheostomy suctioning)
- Discomfort as assessed by the Wong-Baker FACES Pain Rating Scale(During tracheostomy suctioning)
- Occurrence of Stomal Infection(At time of receiving tracheostomy up to approximately 6 weeks)
- Hospital length of stay(An average of 6 weeks)
研究者
研究点 (4)
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