An observational study in Patient Ventilator Interactions, sponsored by Löwenstein Medical Technology GmbH & Co. KG. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Löwenstein Medical Technology GmbH & Co. KG · Observational
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.
24 studies on the registry are indexed under Patient-Ventilator Asynchrony; 11 are open to participants now.
This study's planned enrollment of 78 is above the median of 40 across 13 observational studies indexed under Patient-Ventilator Asynchrony.
Browse Patient-Ventilator Asynchrony studies →Löwenstein Medical Technology GmbH & Co. KG is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with an indication for non-life-sustaining or life-sustaining NIV therapy (initial setup or follow-up visit) treated with a prisma VENT or LUISA ventilator.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Polygraphy-derived Patient-Ventilator Asynchrony Index (AI PG)
Number of patient-ventilator asynchronies identified by routine polygraphy scoring during the first hour of sleep.
Time frame: 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)
Literature-derived Benchmark Asynchrony Index (AI Bench)
Number of literature-defined patient-ventilator asynchronies derived from routine polygraphy scoring.
Time frame: After completion of the last titration night (up to 7 days)
prisma VENT Device-derived Asynchrony Index (AI prisma VENT)
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.
Time frame: 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)
Change in Polygraphy-derived Patient-Ventilator Asynchrony Index
Change of the AIPG between first and last titration night.
Time frame: From PG titration night 1 until the last PG titration night (up to 7 days)
Apnea-Hypopnea Index (AHI)
Apnea-hypopnea index measured by routine polygraphy.
Time frame: 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)
Oxygen desaturation index measured by routine polygraphy.
Time frame: 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)
Mean peripheral oxygen saturation measured during routine polygraphy.
Time frame: 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)
Blood gas analysis parameter measured before and during NIV titration.
Time frame: Before titration night 1 and at the last blood gas analysis obtained during NIV titration (up to 7 days)
Mean Transcutaneous Carbon Dioxide (TcCO₂)
Mean transcutaneous carbon dioxide level measured during NIV titration.
Time frame: During PG titration night 1, PG titration night 2 (if performed), and the last PG titration night (up to 7 days)
Ventilator Acceptance Score
Acceptance of NIV therapy is assessed by qualified staff during routine clinical evaluation using a 0-10 scale, where 0 indicates the worst possible experience and 10 the most pleasant experience.
Time frame: After the last titration night (up to 7 days)
Mask Acceptance Score
Acceptance of the mask is assessed by qualified staff during routine clinical evaluation using a 0-10 scale, where 0 indicates the worst possible experience and 10 the most pleasant experience.
Time frame: After the last titration night (up to 7 days)
Incidence of Adverse Events and Adverse Device Effects
Number of adverse events and adverse device effects occurring during study participation.
Time frame: From enrollment until completion of study participation (up to 7 days)
Plan to share: No
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Löwenstein Medical Technology GmbH & Co. KG