Non-invasive Ventilation in Patients With Interstitial Lung Disease - a Feasibility Study
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 26, 2015
CompletedFirst Posted
Study publicly available on registry
March 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedFebruary 27, 2019
February 1, 2019
4.7 years
February 26, 2015
February 26, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
timespan until sufficient use of noninvasive ventilation > 6h during night
day 4-16
Secondary Outcomes (5)
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 Arms (1)
non-invasive ventilation
EXPERIMENTALpatients will undergo about 14 nights of non-invasive ventilation during pulmonary rehabilitation
Interventions
patients will undergo a nocturnal non-invasive ventilation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Schoen Klinik Berchtesgadener Land
Schönau am Königssee, Bavaria, 83471, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Klaus Kenn, MD
Schoen Klinik Berchtesgadener Land
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. med. Klaus Kenn
Study Record Dates
First Submitted
February 26, 2015
First Posted
March 4, 2015
Study Start
February 1, 2015
Primary Completion
October 1, 2019
Study Completion
December 1, 2019
Last Updated
February 27, 2019
Record last verified: 2019-02