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

Wissenschaftliches Institut Bethanien e.V

Status

Terminated

Conditions

Dyspnea

Noninvasive Ventilation

Treatments

Other: softSTOPP

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04093427

WI_19-090_softSTOPP

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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