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

NCT ID: NCT02377739

Last Updated: 2019-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2019-12-31

Brief Summary

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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

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Conditions

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Noninvasive Ventilation Lung Diseases, Interstitial

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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non-invasive ventilation

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

Group Type EXPERIMENTAL

non-invasive ventilation

Intervention Type OTHER

patients will undergo a nocturnal non-invasive ventilation

Interventions

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non-invasive ventilation

patients will undergo a nocturnal non-invasive ventilation

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Weinmann Geräte für Medizin GmbH + Co. KG

INDUSTRY

Sponsor Role collaborator

Schön Klinik Berchtesgadener Land

OTHER

Sponsor Role lead

Responsible Party

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Klaus Kenn

Dr. med. Klaus Kenn

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Klaus Kenn, MD

Role: PRINCIPAL_INVESTIGATOR

Schoen Klinik Berchtesgadener Land

Locations

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Schoen Klinik Berchtesgadener Land

Schönau am Königssee, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Klaus Kenn, MD

Role: CONTACT

0049865293 ext. 1540

Rainer Gloeckl, PhD

Role: CONTACT

0049865293 ext. 1630

Facility Contacts

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Klaus Kenn, MD

Role: primary

0049865293 ext. 1540

Other Identifiers

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NIV-ILD

Identifier Type: -

Identifier Source: org_study_id

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