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

Primary Purpose

Noninvasive Ventilation, Lung Diseases, Interstitial

Status

Unknown status

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

non-invasive ventilation

About this trial

This is an interventional treatment trial for Noninvasive Ventilation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Schoen Klinik Berchtesgadener LandRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

non-invasive ventilation

Arm Description

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

Outcomes

Primary Outcome Measures

timespan until sufficient use of noninvasive ventilation > 6h during night

Secondary Outcome Measures

6-minute walking test

change in 6-minute walking distance

arterial pressure of carbon dioxide during night

measured transcutaneously by a Sentec device

lung function measured by bodyplethysmograph

measured by bodyplethysmograph

energy expenditure during night assessed by Sensewear Armband

assessed by Sensewear Armband

quality of life

Short-Form-36 health survey, Hospital Anxiety and Depression scale and severe respiratory insufficiency questionnaire

Full Information

NCT ID

NCT02377739

First Posted

February 26, 2015

Last Updated

February 26, 2019

Sponsor

Schön Klinik Berchtesgadener Land

Collaborators

Weinmann Geräte für Medizin GmbH + Co. KG

1. Study Identification

Unique Protocol Identification Number

NCT02377739

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Unknown status

Study Start Date

February 2015 (Actual)

Primary Completion Date

October 2019 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Schön Klinik Berchtesgadener Land

Collaborators

Weinmann Geräte für Medizin GmbH + Co. KG

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Noninvasive Ventilation, Lung Diseases, Interstitial

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

non-invasive ventilation

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

non-invasive ventilation

Intervention Description

patients will undergo a nocturnal non-invasive ventilation

Primary Outcome Measure Information:

Title

timespan until sufficient use of noninvasive ventilation > 6h during night

Time Frame

day 4-16

Secondary Outcome Measure Information:

Title

6-minute walking test

Description

change in 6-minute walking distance

Time Frame

day 1-3 and day 17-19

Title

arterial pressure of carbon dioxide during night

Description

measured transcutaneously by a Sentec device

Time Frame

day 1-3 and day 17-19

Title

lung function measured by bodyplethysmograph

Description

measured by bodyplethysmograph

Time Frame

day 1-3 and 17-19

Title

energy expenditure during night assessed by Sensewear Armband

Description

assessed by Sensewear Armband

Time Frame

day 5 and 15

Title

quality of life

Description

Short-Form-36 health survey, Hospital Anxiety and Depression scale and severe respiratory insufficiency questionnaire

Time Frame

day 1-3 and 17-19

10. Eligibility

Sex

All

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Klaus Kenn, MD

Phone

0049865293

Ext

1540

KKenn@Schoen-Kliniken.de

First Name & Middle Initial & Last Name or Official Title & Degree

Rainer Gloeckl, PhD

Phone

0049865293

Ext

1630

rgloeckl@schoen-kliniken.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Klaus Kenn, MD

Organizational Affiliation

Schoen Klinik Berchtesgadener Land

Official's Role

Principal Investigator

Facility Information:

Facility Name

Schoen Klinik Berchtesgadener Land

City

Schoenau Am Koenigssee

State/Province

Bayern

ZIP/Postal Code

83471

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Klaus Kenn, MD

Phone

0049865293

Ext

1540

KKenn@Schoen-Kliniken.de

12. IPD Sharing Statement

Learn more about this trial

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

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