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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Klinikum Berchtesgadener Land der Schön-Kliniken

Current Primary Outcome: timespan until sufficient use of noninvasive ventilation > 6h during night [ Time Frame: day 4-16 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Klinikum Berchtesgadener Land der Schön-Kliniken

Dates:
Date Received: February 26, 2015
Date Started: February 2015
Date Completion: November 2017
Last Updated: October 7, 2016
Last Verified: October 2016