Lung Diseases, Interstitial, Noninvasive Ventilation
Conditions
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.
Interventions
OTHERnon-invasive ventilation
patients will undergo a nocturnal non-invasive ventilation
Sponsors
Weinmann Geräte für Medizin GmbH + Co. KG
Schön Klinik Berchtesgadener Land
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| timespan until sufficient use of noninvasive ventilation > 6h during night | day 4-16 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6-minute walking test | day 1-3 and day 17-19 | change in 6-minute walking distance |
| arterial pressure of carbon dioxide during night | day 1-3 and day 17-19 | measured transcutaneously by a Sentec device |
| lung function measured by bodyplethysmograph | day 1-3 and 17-19 | measured by bodyplethysmograph |
| energy expenditure during night assessed by Sensewear Armband | day 5 and 15 | assessed by Sensewear Armband |
| quality of life | day 1-3 and 17-19 | Short-Form-36 health survey, Hospital Anxiety and Depression scale and severe respiratory insufficiency questionnaire |
Countries
Germany
Contacts
Primary ContactKlaus Kenn, MD
Backup ContactRainer Gloeckl, PhD
Outcome results
None listed