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Clinical Trials/NCT02377739
NCT02377739
Unknown
Not Applicable

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

Schön Klinik Berchtesgadener Land1 site in 1 country30 target enrollmentFebruary 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Noninvasive Ventilation
Sponsor
Schön Klinik Berchtesgadener Land
Enrollment
30
Locations
1
Primary Endpoint
timespan until sufficient use of noninvasive ventilation > 6h during night
Last Updated
7 years ago

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.

Registry
clinicaltrials.gov
Start Date
February 2015
End Date
December 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Klaus Kenn

Dr. med. Klaus Kenn

Schön Klinik Berchtesgadener Land

Eligibility Criteria

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

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)

Study Sites (1)

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