Status:
TERMINATED
Influence of an Inverse Pressure Ramp in Long-term Non-invasive Ventilation on Dyspnea in the Morning After Therapy
Lead Sponsor:
Wissenschaftliches Institut Bethanien e.V
Collaborating Sponsors:
Löwenstein Medical Technology GmbH & Co. KG
Conditions:
Noninvasive Ventilation
Dyspnea
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2022
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04093427
Start Date
August 1 2019
End Date
July 31 2022
Last Update
December 21 2023
Active Locations (1)
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1
Krankenhaus Bethanien
Solingen, North Rhine-Westphalia, Germany, 42699