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Trial record 20 of 3664 for:    Recruiting, Not yet recruiting, Available Studies | "Lung Diseases"

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

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ClinicalTrials.gov Identifier: NCT02377739
Recruitment Status : Recruiting
First Posted : March 4, 2015
Last Update Posted : February 15, 2018
Sponsor:
Collaborator:
Weinmann Geräte für Medizin GmbH + Co. KG
Information provided by (Responsible Party):
Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken

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.

Condition or disease Intervention/treatment Phase
Noninvasive Ventilation Lung Diseases, Interstitial Other: non-invasive ventilation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-invasive Ventilation in Patients With Interstitial Lung Disease - a Feasibility Study
Actual Study Start Date : February 2015
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: non-invasive ventilation
patients will undergo about 14 nights of non-invasive ventilation during pulmonary rehabilitation
Other: non-invasive ventilation
patients will undergo a nocturnal non-invasive ventilation




Primary Outcome Measures :
  1. timespan until sufficient use of noninvasive ventilation > 6h during night [ Time Frame: day 4-16 ]

Secondary Outcome Measures :
  1. 6-minute walking test [ Time Frame: day 1-3 and day 17-19 ]
    change in 6-minute walking distance

  2. arterial pressure of carbon dioxide during night [ Time Frame: day 1-3 and day 17-19 ]
    measured transcutaneously by a Sentec device

  3. lung function measured by bodyplethysmograph [ Time Frame: day 1-3 and 17-19 ]
    measured by bodyplethysmograph

  4. energy expenditure during night assessed by Sensewear Armband [ Time Frame: day 5 and 15 ]
    assessed by Sensewear Armband

  5. quality of life [ Time Frame: day 1-3 and 17-19 ]
    Short-Form-36 health survey, Hospital Anxiety and Depression scale and severe respiratory insufficiency questionnaire



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02377739


Contacts
Contact: Klaus Kenn, MD 0049865293 ext 1540 KKenn@Schoen-Kliniken.de
Contact: Rainer Gloeckl, PhD 0049865293 ext 1630 rgloeckl@schoen-kliniken.de

Locations
Germany
Schoen Klinik Berchtesgadener Land Recruiting
Schoenau Am Koenigssee, Bayern, Germany, 83471
Contact: Klaus Kenn, MD    0049865293 ext 1540    KKenn@Schoen-Kliniken.de   
Sponsors and Collaborators
Klinikum Berchtesgadener Land der Schön-Kliniken
Weinmann Geräte für Medizin GmbH + Co. KG
Investigators
Principal Investigator: Klaus Kenn, MD Schoen Klinik Berchtesgadener Land

Responsible Party: Klaus Kenn, Dr. med. Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken
ClinicalTrials.gov Identifier: NCT02377739     History of Changes
Other Study ID Numbers: NIV-ILD
First Posted: March 4, 2015    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases