Non-invasive Ventilation in Patients With Interstitial Lung Disease - a Feasibility Study

Schön Klinik Berchtesgadener Land

Status: Unknown

Conditions: Lung Diseases, Interstitial; Noninvasive Ventilation

Treatments: Other: non-invasive ventilation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02377739

NIV-ILD

Details and patient eligibility

About

The efficiency of non-invasive ventilation (NIV) in hypercapnic patients with chronic obstructive pulmonary disease during pulmonary rehabilitation has been shown in numerous studies. There is only a limited number of therapeutic options for patients with severely progressed interstitial lung disease (ILD). The question whether chronic hypercapnic ILD-patients are able to profit from nocturnal NIV and thus increase their performance in physical training has been left unknown. Therefore, this study aims to evaluate the feasibility of the initialization of a NIV for hypercapnic ILD-patients during pulmonary rehabilitation.

Enrollment: 30 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• confirmed diagnosis of Interstitial lung disease
• Hypercapnia defined as carbon dioxide partial pressure ≥45 mmHg (at rest, night or activity)
• already existing but not sufficient and regular use of non-invasive ventilation (≤3h/24h)
• patients consent to participate in this trial

Exclusion criteria

• acute pulmonary insufficiency (ph<7.35)
• acute, clinically relevant heart disease
• already existing and sufficient use of non-invasive ventilation (≥3h/24h)
• Body-Mass-Index>30
• obstructive sleep apnea
• Intolerance to perform non-invasive ventilation
• acute infection

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

non-invasive ventilation

Experimental group

Description:

patients will undergo about 14 nights of non-invasive ventilation during pulmonary rehabilitation

Treatment:

Other: non-invasive ventilation