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

Lung Diseases, Interstitial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02377739
• Other study ID #: NIV-ILD
• Status: Recruiting
• Phase: N/A
• Start date: February 2015
• Est. completion date: December 2019

Study information

• Verified date: February 2019
• Source: Klinikum Berchtesgadener Land der Schön-Kliniken
• Contact: Klaus Kenn, MD
• Phone: 0049865293
• Email: KKenn[@]Schoen-Kliniken.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Interstitial
• Noninvasive Ventilation

Intervention

Other:
• non-invasive ventilation
patients will undergo a nocturnal non-invasive ventilation

Locations

Country	Name	City	State
Germany	Schoen Klinik Berchtesgadener Land	Schoenau Am Koenigssee	Bayern

Sponsors (2)

Lead Sponsor	Collaborator
Klinikum Berchtesgadener Land der Schön-Kliniken	Weinmann Geräte für Medizin GmbH + Co. KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	timespan until sufficient use of noninvasive ventilation > 6h during night		day 4-16
Secondary	6-minute walking test	change in 6-minute walking distance	day 1-3 and day 17-19
Secondary	arterial pressure of carbon dioxide during night	measured transcutaneously by a Sentec device	day 1-3 and day 17-19
Secondary	lung function measured by bodyplethysmograph	measured by bodyplethysmograph	day 1-3 and 17-19
Secondary	energy expenditure during night assessed by Sensewear Armband	assessed by Sensewear Armband	day 5 and 15
Secondary	quality of life	Short-Form-36 health survey, Hospital Anxiety and Depression scale and severe respiratory insufficiency questionnaire	day 1-3 and 17-19