Health Trials

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

ConditionPatient Ventilator Interactions
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorLöwenstein Medical Technology GmbH & Co. KG

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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)
2

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)
3

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)

Secondary outcomes

1

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)
2

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)
3

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)
4

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Löwenstein Medical Technology GmbH & Co. KG

Lead sponsor

Source ClinicalTrials.gov
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