Safety, Feasibility, and Impact on Pulmonary Secretion Management Comparing the Use of TrachPhone and External Humidifier After Tracheostomy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Number of suctioning per day
研究概览
简要总结
The use of Heat and Moisture Exchangers (HMEs) and their positive impact on pulmonary health have been extensively studied in patients with head and neck cancer but have not been systematically explored in other patient populations breathing through a neck stoma.
The objective of this clinical investigation is to compare the use of HMEs to the use of External Humidifiers (EHs) on pulmonary secretion management, their usability and safety, for humidifying inhaled air in patients that received a tracheostomy due to a neurological condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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 patient outside critical care
- •Self-ventilating via a tracheostomy tube, independent of cuff status
- •18 years or older
排除标准
- •Patients with tidal volume beyond recommended range (50-1000 ml)
- •Dehydration
- •Very heavy/excessive secretion from the lungs and airways (requiring more frequently tracheal suction, more than hourly suctioning)
- •High oxygen need (FiO2 > 0.4)
- •Acutely deteriorating patient
研究组 & 干预措施
Arm 2 - EH
24/7 use of EH until first follow-up (T1), then 24/7 use of TrachPhone HME for the remainder of the study participation.
干预措施: TrachPhone HME (Device)
Arm 2 - EH
24/7 use of EH until first follow-up (T1), then 24/7 use of TrachPhone HME for the remainder of the study participation.
干预措施: External Humidifier (Usual Care) (Device)
Arm 1 - HME
24/7 use of TrachPhone HME for the entirety of study
干预措施: TrachPhone HME (Device)
结局指标
主要结局
Number of suctioning per day
时间窗: At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)
Times per day suctioning is required
次要结局
- Time needed for suctioning(At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks))
- Quality of Life by EQ-5D-5L(At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks))
- Patient preference(Upon discharge from the hospital (on average after 3 weeks))
- Use of TrachPhone(At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks))
- Quality of secretion(At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks))
- Nursing time regarding device use(At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks))
- Adherence to use of devices(At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks))
- Patient communication(At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks))
- Oxygen needs(At Baseline, T1 follow-up, and TX follow-ups every 10-14 days until discharge)
- Adverse Events(Through study completion, an average of 1 year)
- Voice Quality(At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks))
- Patient mobility(Upon discharge of the last participant, on average after 1 year)
- Nurse and therapy team feedback(Upon discharge of the last participant, on average after 1 year)