Device fabrication and clinical validation of a novel mechanical handheld suction device for tracheostomy tube cleaning: A pilot study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- A novel mechanical hand held simple suction device will be formulated and clinically tested
研究概览
简要总结
A novel mechanical hand held suction device will be fabricated and will be clinically validated. This study will take place in in-patient and out- patient department of Otorhinolaryngology in AIIMS, New Delhi in collaboration with NIFT, New Delhi. Fabrication of 10 number of prototypes of the suction device will be done according to negative pressure requirement for each size. There will be 3 size of the suction device. In clinical validation, each size suction device will be used in 10 patients at 50 different occasions. The efficacy will be graded by trained medical professionals and care givers of the patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 0.00 Day(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Willing to participate in the study.
- •Any age or gender.
- •Tracheostomized for more than 48 hours.
排除标准
- •VERY SICK PATIENT ON MECHANICAL VENTOLATOR SUPPORT
- •UNCONSIOUS PATIENTS
- •NOT WILLING TO PARTICIPATE IN STUDY.
结局指标
主要结局
A novel mechanical hand held simple suction device will be formulated and clinically tested
时间窗: A novel mechanical hand held simple suction device will be formulated and clinically tested at 5 different occasions in each patient. It will be done after 2 days of usage.
次要结局
- 1. To measure the negative pressure created in already existing suction devices(2. to validate the clinical efficacy of the three sizes- small medium and large)
研究者
Dr. Ritu Dudi
AIIMS, New Delhi