Non-invasive Ventilation in Patients With Interstitial Lung Disease - a Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- timespan until sufficient use of noninvasive ventilation > 6h during night
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
non-invasive ventilation
patients will undergo about 14 nights of non-invasive ventilation during pulmonary rehabilitation
Intervention: non-invasive ventilation (Other)
Outcomes
Primary Outcomes
timespan until sufficient use of noninvasive ventilation > 6h during night
Time Frame: day 4-16
Secondary Outcomes
- 6-minute walking test(day 1-3 and day 17-19)
- arterial pressure of carbon dioxide during night(day 1-3 and day 17-19)
- lung function measured by bodyplethysmograph(day 1-3 and 17-19)
- energy expenditure during night assessed by Sensewear Armband(day 5 and 15)
- quality of life(day 1-3 and 17-19)
Investigators
Klaus Kenn
Dr. med. Klaus Kenn
Schön Klinik Berchtesgadener Land