Analysis and Evaluation of Asynchronies Between NIV Patients and Their Prisma VENT or LUISA Ventilator

Extended Evaluation of Asynchrony Detection of the Prisma VENT and LUISA Therapy Devices in Ventilated (NIV) Patients ("NIV_Event")

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.

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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