Patient Ventilator InteractionsNCT07768748
Analysis and Evaluation of Asynchronies Between NIV Patients and Their Prisma VENT or LUISA Ventilator
An observational study of Patient Ventilator Interactions, run by Löwenstein Medical Technology GmbH & Co. KG at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Patient Ventilator Interactions
- How many people
- 78 participants
- Where
- 1 siteGermany
- Study dates
- 15 Aug 2026to 15 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Fachkrankenhaus Kloster Grafschaft GmbH
Schmallenberg, North Rhine-Westphalia, 57392
Jens Kerl, PD Dr. rer. nat., +49 2972 7911703, j.kerl@fkkg.de
Stephan Pieper, +49 2972 7913179, s.pieper@fkkg.de
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Patient Ventilator Interactions
- Keywords
- non-invasive ventilation, Patient Ventilator Asynchronies, Polysomnography, LUISA, prisma VENT, LENA, Full Face Mask, Patient-ventilator interaction, adult, Event detection, Respiratory monitoring, Breathing pattern, Long-term ventilation, ventilation quality, oronasal mask
- Medical subject headings
- Patient-Ventilator Asynchrony
What is being measured
The primary outcome is the main question the study is designed to answer.
Polygraphy-derived Patient-Ventilator Asynchrony Index (AI PG)
Number of patient-ventilator asynchronies identified by routine polygraphy scoring during the first hour of sleep.
Measured: 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.
Measured: 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.
Measured: 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)
Secondary outcomes (9)
Change in Polygraphy-derived Patient-Ventilator Asynchrony Index
Change of the AIPG between first and last titration night.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment until completion of study participation (up to 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start15 Aug 2026
- Primary completion15 Aug 2028 (estimated)
- Study completion15 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Ventilator InteractionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Löwenstein Medical Technology GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768748
- Sponsor's protocol ID
- N5V2_NIV_EVENT
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Evaluation of Asynchrony Detection of the Prisma VENT and LUISA Therapy Devices in Ventilated (NIV) Patients ("NIV_Event")
- ClinicalTrials.gov ID
- NCT07768748
- Acronym / sponsor ID
- N5V2_NIV_EVENT
- Conditions
- Patient Ventilator Interactions
- Keywords
- non-invasive ventilation, Patient Ventilator Asynchronies, Polysomnography, LUISA, prisma VENT, LENA, Full Face Mask, Patient-ventilator interaction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Löwenstein Medical Technology GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2026 (actual)
- Primary completion
- 15 Aug 2028 (estimated)
- Study completion
- 15 Dec 2028 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Polygraphy-derived Patient-Ventilator Asynchrony Index (AI PG)
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)
Number of patient-ventilator asynchronies identified by routine polygraphy scoring during the first hour of sleep.
Literature-derived Benchmark Asynchrony Index (AI Bench)
Time frame: 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)
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)
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.
9 secondary outcomes
Change in Polygraphy-derived Patient-Ventilator Asynchrony Index
Time frame: From PG titration night 1 until the last PG titration night (up to 7 days)
Apnea-Hypopnea Index (AHI)
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)
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)
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)
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)
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
Time frame: After the last titration night (up to 7 days)
Mask Acceptance Score
Time frame: After the last titration night (up to 7 days)
Incidence of Adverse Events and Adverse Device Effects
Time frame: From enrollment until completion of study participation (up to 7 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Karagiannidis C, Strassmann S, Callegari J, Kochanek M, Janssens U, Windisch W. Evolving Epidemiology of Home Mechanical Ventilation: A Rapidly Growing Challenge for Patient Care. Dtsch Med Wochenschr. 2019;144(9):E58-E63. doi:10.1055/a-0758-4512.Link provided by the sponsor.
- Haro CD, Ochagavia A, López-Aguilar J, et al. Patient-ventilator asynchronies during me-chanical ventilation: Current knowledge and research priorities. Intensive Care Medicine Experimental. 2019;7. doi:10.1186/s40635-019-0234-5.Link provided by the sponsor.
- Kerl J, Dellweg D. Nicht invasive nächtliche Beatmung bei COPD. Schlaf. 2017;06(03):134-140. doi:10.1055/s-0038-1626178Link provided by the sponsor.
- Blanch L, Villagra A, Sales B, et al. Asynchronies during mechanical ventilation are associ-ated with mortality. Intensive Care Med. 2015. doi:10.1007/s00134-015-3692-6.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Ventilator Interactions, run by Löwenstein Medical Technology GmbH & Co. KG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Regina Schäfer (+49 151 72421355, regina.schaefer@loewensteinmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polygraphy-derived Patient-Ventilator Asynchrony Index (AI PG) (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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.