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

NCT04093427 — Not applicable, Terminated, 8 participants, Wissenschaftliches Institut Bethanien e.V

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Einfluss Einer Inversen Druckrampe Bei Der Langzeit-Therapie Mit Nicht-invasiver Ventilation Auf Dyspnoe am Morgen Nach Therapie-Ende. Influence of an Inverse Pressure Ramp in the Long-term Therapy Mit Non-invasive Ventilation on Dyspnea in the Morning After Therapy.

Registry	NCT04093427
Status	Terminated - Insufficient recruitment in a timely manner
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	8 (Actual)
Sponsor	Wissenschaftliches Institut Bethanien e.V (Other); collaborators: Löwenstein Medical Technology GmbH & Co. KG
Conditions	Noninvasive Ventilation, Dyspnea
Interventions	softSTOPP (Other)
Dates	start 2019-08-01, primary completion 2022-07-31, completion 2022-07-31, first posted 2019-09-18, last updated 2023-12-21
Locations	1 site in Germany

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
softSTOPP active	Active comparator	Other: softSTOPP
softSTOPP inactive	No intervention

softSTOPP (Other): Non-invasive ventilation device setting in prismaVENT 30 device enabling an inverse pressure ramp after therapy end

+Outcome measures

Primary outcomes

Change of dyspnea level from baseline to 12 weeks [12 weeks]: Delta value of morning dyspnea from baseline to 12 weeks as measured by the Borg Scale. The Borg Scale ranges from 0 (no perceived dyspnea at all) to 10 (maximum perceived dyspnea).

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Krankenhaus Bethanien	Solingen, North Rhine-Westphalia	Germany

+Investigators

Winfried J Randerath, Prof. Dr., Principal investigator, Krankenhaus Bethanien