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

Dyspnea Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04093427
• Other study ID #: WI_19-090_softSTOPP
• Status: Terminated
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: July 31, 2022

Study information

• Verified date: December 2023
• Source: Wissenschaftliches Institut Bethanien e.V
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyspnea
• Noninvasive Ventilation

Intervention

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

Locations

Country	Name	City	State
Germany	Krankenhaus Bethanien	Solingen	NRW

Sponsors (2)

Lead Sponsor	Collaborator
Wissenschaftliches Institut Bethanien e.V	Löwenstein Medical Technology GmbH & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of dyspnea level from baseline to 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).	12 weeks