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Influence of an Inverse Pressure Ramp in Long-term Non-invasive Ventilation on Dyspnea in the Morning After Therapy

NCT04093427 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2023-12-21

No results posted yet for this study

Summary

Patients being treated with non-invasive home mechanical ventilation (NIV) may experience morning dyspnea after each night of NIV use, when the therapy is abruptly ended. This study aims to show that dyspnea intensity can be significantly reduced by a gentle NIV therapy end, delivered by a continuously decreasing pressure level (inverse pressure ramp) after therapy end in the morning, a feature called softSTOPP, which can configured in prismaVENT NIV devices. This could also improve therapy adherence.

Conditions

Interventions

OTHER

softSTOPP

Non-invasive ventilation device setting in prismaVENT 30 device enabling an inverse pressure ramp after therapy end

Sponsors & Collaborators

  • Löwenstein Medical Technology GmbH & Co. KG

    collaborator INDUSTRY

  • Wissenschaftliches Institut Bethanien e.V

    lead OTHER

Principal Investigators

  • Winfried J Randerath, Prof. Dr. · Krankenhaus Bethanien

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2022-07-31
Completion
2022-07-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04093427 on ClinicalTrials.gov