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

Not Applicable

• Conditions: Lung Diseases, Interstitial; Noninvasive Ventilation
• Interventions: Other: non-invasive ventilation

• Registration Number: NCT02377739
• Lead Sponsor: Schön Klinik Berchtesgadener Land

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 Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-26
• Study First Submitted QC: 2015-03-03
• Study First Posted: 2015-03-04
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-26
• Last Update Posted: 2019-02-27
• Primary Completion: 2019-10
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
non-invasive ventilation	non-invasive ventilation	patients will undergo about 14 nights of non-invasive ventilation during pulmonary rehabilitation

Primary Outcome Measures

Name	Time	Method
timespan until sufficient use of noninvasive ventilation > 6h during night	day 4-16

Secondary Outcome Measures

Name	Time	Method
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
arterial pressure of carbon dioxide during night	day 1-3 and day 17-19	measured transcutaneously by a Sentec device
6-minute walking test	day 1-3 and day 17-19	change in 6-minute walking distance
quality of life	day 1-3 and 17-19	Short-Form-36 health survey, Hospital Anxiety and Depression scale and severe respiratory insufficiency questionnaire

Trial Locations

Locations (1)

Schoen Klinik Berchtesgadener Land; 🇩🇪 Schoenau Am Koenigssee, Bayern, Germany