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

Study Overview
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Brief Summary
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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.

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

Conditions
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Noninvasive Ventilation, Lung Diseases, Interstitial

Intervention / Treatment
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* Other: non-invasive ventilation


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: non-invasive ventilation<br>patients will undergo about 14 nights of non-invasive ventilation during pulmonary rehabilitation | Other: non-invasive ventilation<br>* patients will undergo a nocturnal non-invasive ventilation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| timespan until sufficient use of noninvasive ventilation > 6h during night |  | day 4-16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-minute walking test | change in 6-minute walking distance | day 1-3 and day 17-19 | 
| arterial pressure of carbon dioxide during night | measured transcutaneously by a Sentec device | day 1-3 and day 17-19 | 
| lung function measured by bodyplethysmograph | measured by bodyplethysmograph | day 1-3 and 17-19 | 
| energy expenditure during night assessed by Sensewear Armband | assessed by Sensewear Armband | day 5 and 15 | 
| quality of life | Short-Form-36 health survey, Hospital Anxiety and Depression scale and severe respiratory insufficiency questionnaire | day 1-3 and 17-19 |