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

NCT ID: NCT04093427

Last Updated: 2023-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2022-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Noninvasive Ventilation Dyspnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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softSTOPP active

Group Type ACTIVE_COMPARATOR

softSTOPP

Intervention Type OTHER

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

softSTOPP inactive

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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softSTOPP

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Diagnosis of a chronic obstructive pulmonary disease (COPD) with chronic hypercapnic insufficiency
* Therapy with prismaVENT 30, firmware V 3.3 or higher, mode S/T, stable device settings at the time of inclusion without need to adapt ventilation parameters
* May have co-existing obstructive sleep apnea syndrome
* Subjective dyspnea ≥3 (Borg scale) after end of ventilation therapy in the morning
* Written informed consent for study participation including data protection

Exclusion Criteria

* Missing written informed consent for study participation including data protection
* Contraindication for positive airway pressure therapy
* Use of the softSTOPP feature before study inclusion
* Participation in another study, which influences NIV therapy by defining device settings or titration
* Concomitant oxygen therapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Löwenstein Medical Technology GmbH & Co. KG

INDUSTRY

Sponsor Role collaborator

Wissenschaftliches Institut Bethanien e.V

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Winfried J Randerath, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Krankenhaus Bethanien

Locations

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Krankenhaus Bethanien

Solingen, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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WI_19-090_softSTOPP

Identifier Type: -

Identifier Source: org_study_id