Non-invasive Ventilation in Patients With Interstitial Lu... | NCT02377739

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

NCT02377739

Sponsor

Schön Klinik Berchtesgadener Land

Status

Unknown status

Last Update Posted

Feb 27, 2019Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Noninvasive Ventilation
Lung Diseases, Interstitial

Interventions

non-invasive ventilation

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015Actual

Primary Completion Date

Oct 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Feb 26, 2015

First Submission Date that Met QC Criteria

Mar 3, 2015

First Posted Date

Mar 4, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2019

Last Update Posted Date

Feb 27, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Klaus Kenn, Dr. med. Klaus Kenn, Schön Klinik Berchtesgadener LandPrincipal Investigator

Lead Sponsor

Schön Klinik Berchtesgadener LandOTHER

Collaborators

Name	Class
Weinmann Geräte für Medizin GmbH + Co. KG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
non-invasive ventilation	Experimental	patients will undergo about 14 nights of non-invasive ventilation during pulmonary rehabilitation	Other: non-invasive ventilation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
non-invasive ventilation	Other	patients will undergo a nocturnal non-invasive ventilation	non-invasive ventilation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
timespan until sufficient use of noninvasive ventilation > 6h during night		day 4-16

Secondary Outcomes

Measure	Description	Time Frame
6-minute walking test	change in 6-minute walking distance	day 1-3 and day 17-19
arterial pressure of carbon dioxide during night	measured transcutaneously by a Sentec device

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Klaus Kenn, MD	Contact	0049865293	1540	KKenn@Schoen-Kliniken.de
Rainer Gloeckl, PhD	Contact	0049865293	1630	rgloeckl@schoen-kliniken.de

Overall Officials

Name	Affiliation	Role
Klaus Kenn, MD	Schoen Klinik Berchtesgadener Land	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Schoen Klinik Berchtesgadener Land	Recruiting	Schönau am Königssee	Bavaria	83471	Germany

Condition Browse Module

MeSH Terms

ID	Term
D017563	Lung Diseases, Interstitial

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D063087	Noninvasive Ventilation

Ancestor Terms

ID	Term
D012121	Respiration, Artificial
D058109	Airway Management
D013812	Therapeutics
D012138	Respiratory Therapy

Browse Leaves

Not provided

Browse Branches

Not provided