Extended Evaluation of Asynchrony Detection of the Prisma VENT and LUISA Therapy Devices in Ventilated (NIV) Patients ("NIV_Event")
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Polygraphy-derived Patient-Ventilator Asynchrony Index (AI PG)
研究概览
简要总结
This study aims to analyze the types, rates, and patterns of disturbances between the breathing of patients receiving non-invasive ventilation and their ventilator (patient-ventilator asynchronies, PVA) during routine therapy initiations and follow-up visits. Furthermore, it evaluates the impact of patient-ventilator asynchronies on the quality and duration of therapy settings and adjustments.
详细描述
Diseases of the respiratory system, which essentially manifest as limitations of central respiratory control, the respiratory muscles, their innervating nerves, and respiratory mechanics, result in ventilatory disorders. Chronic ventilatory insufficiency and the frequently resulting chronic hypercapnic respiratory insufficiency (CHRI) require treatment with mechanical ventilation (MV) to augment ventilation¹. Depending on the type and severity of the underlying disease, MV is provided either invasively via an endotracheal tube or tracheostomy, or non-invasively using a mask (NIV).
The number of patients receiving long-term NIV in Germany has increased significantly over the past 20 years². This is likely attributable to the increasing life expectancy of the population as well as more recent findings from clinical research demonstrating positive effects of home NIV on symptoms and quality of life in various diseases³.
A strong predictor of successful NIV therapy is the quality of the interaction between the patient and the ventilator, which can be adversely affected by so-called patient-ventilator asynchronies⁴˒⁵. Furthermore, a high proportion of patient-ventilator asynchronies (asynchrony index) is associated with increased mortality⁶. Therefore, the systematic assessment of patient-ventilator asynchronies (PVA) is of clinical relevance.
This clinical investigation descriptively examines the influence of the types, frequencies, and patterns of patient-ventilator asynchronies during routine NIV initiation and NIV follow-up assessments on the duration of the titration process and the success of the initial treatment phase. The objective is to further develop and optimize the asynchrony detection capabilities of both devices.
This clinical investigation is exploratory in nature. A comparison between the prisma VENT and LUISA devices is not part of this clinical investigation.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •indication for non-life-sustaining or life-sustaining NIV therapy (initial setup) or an existing non-life-sustaining or life-sustaining NIV therapy
- •treatment with a prisma VENT or LUISA therapy device according to clinical routine
- •age of study participants: ≥ 18 and ≤ 80 years
- •capacity to give consent
- •availability of a signed informed consent form for participation in the clinical trial and a signed consent form for data use in accordance with the GDPR
排除标准
- •presence of a contraindication to NIV therapy
- •participation in another clinical investigation that affects the initiation of NIV therapy through specifications regarding device settings or titration
- •pregnancy or breastfeeding
结局指标
主要结局
Polygraphy-derived Patient-Ventilator Asynchrony Index (AI PG)
时间窗: During the first hour of sleep in PG titration night 1, PG titration night 2 (if performed), and the last PG titration night (up to 7 days)
Number of patient-ventilator asynchronies identified by routine polygraphy scoring during the first hour of sleep.
Literature-derived Benchmark Asynchrony Index (AI Bench)
时间窗: After completion of the last titration night (up to 7 days)
Number of literature-defined patient-ventilator asynchronies derived from routine polygraphy scoring.
prisma VENT Device-derived Asynchrony Index (AI prisma VENT)
时间窗: During the first hour of sleep in PG titration night 1, PG titration night 2 (if performed), and the last PG titration night (up to 7 days)
Number of automatically detected patient-ventilator asynchronies identified by prisma VENT devices per first hour of sleep. Applicable only for participants treated with prisma VENT.
次要结局
- Change in Polygraphy-derived Patient-Ventilator Asynchrony Index(From PG titration night 1 until the last PG titration night (up to 7 days))
- Apnea-Hypopnea Index (AHI)(During PG titration night 1, PG titration night 2 (if performed), and the last PG titration night (up to 7 days))
- Oxygen Desaturation Index (ODI)(During PG titration night 1, PG titration night 2 (if performed), and the last PG titration night (up to 7 days))
- Mean Oxygen Saturation (SpO₂)(During PG titration night 1, PG titration night 2 (if performed), and the last PG titration night (up to 7 days))
- Partial Pressure of Carbon Dioxide (PaCO₂)(Before titration night 1 and at the last blood gas analysis obtained during NIV titration (up to 7 days))
- Mean Transcutaneous Carbon Dioxide (TcCO₂)(During PG titration night 1, PG titration night 2 (if performed), and the last PG titration night (up to 7 days))
- Ventilator Acceptance Score(After the last titration night (up to 7 days))
- Mask Acceptance Score(After the last titration night (up to 7 days))
- Incidence of Adverse Events and Adverse Device Effects(From enrollment until completion of study participation (up to 7 days))