Intratracheal Sealing of Tracheostomy Immediately After Decannulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Feasibilty
研究概览
简要总结
The purpose of this study is to investigate a new treatment method for tracheostomies - the term for the opening you have in your neck.
The treatment method seals the stoma tract from within the trachea. The aim is to improve lung function and voice quality, as well as to promote wound healing.
Study procedure: A silicone sealing device will be inserted into the stoma tract. This may cause temporary discomfort around the site and may induce some coughing. You will then undergo a pulmonary function test - also known as a spirometry test.
For the following 7 days, the sealing device will remain in the stoma tract and provide an airtight seal. You will be examined daily with spirometry, and the healing of the stoma tract will be closely monitored. A member of the research team will be present with you around the clock to ensure that the device remains correctly positioned. This is a safety precaution in the unlikely event that the sealing device dislocates into the airway.
After 7 days, the sealing device will be removed through the nearly healed stoma tract simply by pulling it out. This may again cause slight irritation or coughing.
详细描述
Background Tracheostomy is a surgical opening in the airway, most commonly performed as part of mechanical ventilation therapy.
It is the most frequently performed surgical procedure in critically ill patients admitted to intensive care units (ICUs) worldwide.
Based on the background literature, we estimate that approximately 1 million tracheostomies are performed globally each year.
An international study found that 24% of ventilated ICU patients were treated through a tracheostomy.
A tracheostomy is formed by creating an open channel from the trachea to the skin surface, typically located just above the sternum. The tract is kept open using a tracheostomy cannula, through which the patient breathes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Tracheostomy in place for ≥7 days for the purpose of mechanical ventilation in ICU
- •Age ≥18 years
- •Uncuffed or occluded tracheostomy tube (size 7-8) during the last 24 hours
排除标准
- •Cognitive impairment or incapacity to such a degree that the participant is unable to comprehend study information or cooperate with the required assessments
结局指标
主要结局
Feasibilty
时间窗: From inrollment to the end of treatment (maximum 7 days)
Ease of device insertion, intratracheal placement, and removal will be assessed by the operating clinician immediately after each procedure. The evaluation will be based on a structured qualitative rating (easy, moderate, difficult) informed by the operator's direct experience and the patient's oral feedback during the procedure.The unit of measure will be the number of procedures rated in each category.
Patient satisfaction (Questionnaire-Based Score)
时间窗: Filled out on the last day of dataretrieval (day 3-7)
Patient satisfaction will be assessed using a structured questionnaire consisting of six items, each rated on a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied). Scores from individual items will be summarized by reporting the median (IQR) for each item across patients. The unit of measure will be the patient-reported score (range 1-5).
次要结局
- Forced Expiratory Volume in 1 Second (FEV₁) measured by spirometry(From enrollment and until removal of the device (up to 7 days after enrollment))
- Tracheostomy wound healing status (photographic evaluation)(From enrollment and until removal of the device (up to 7 days after enrollment))
- Forced Vital Capacity (FVC) measured by spirometry(From enrollment and until removal of the device (up to 7 days after enrollment))
- Peak Expiratory Flow (PEF) measured by spirometry(From enrollment and until removal of the device (up to 7 days after enrollment))
- Voice quality score(From enrollment and until removal of the device (up to 7 days after enrollment))