Noninvasive VentilationNCT02377739
Non-invasive Ventilation in Patients With Interstitial Lung Disease - a Feasibility Study
A study testing non-invasive ventilation in people with Noninvasive Ventilation and Lung Diseases, Interstitial, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Noninvasive Ventilation, Lung Diseases, Interstitial
- What is being tested?
- non-invasive ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2015to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Schoen Klinik Berchtesgadener Land
Schönau am Königssee, Bavaria, 83471
Klaus Kenn, MD, 0049865293 ext. 1540, KKenn@Schoen-Kliniken.de
About this study
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.
- Being tested
- non-invasive ventilation
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive ventilationOther
patients will undergo a nocturnal non-invasive ventilation
| Study group | Role | What they receive |
|---|---|---|
| non-invasive ventilation | Experimental | patients will undergo about 14 nights of non-invasive ventilation during pulmonary rehabilitation Receives: Other: non-invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
timespan until sufficient use of noninvasive ventilation > 6h during night
Measured: day 4-16
Secondary outcomes (5)
6-minute walking test
change in 6-minute walking distance
Measured: day 1-3 and day 17-19
arterial pressure of carbon dioxide during night
measured transcutaneously by a Sentec device
Measured: day 1-3 and day 17-19
lung function measured by bodyplethysmograph
measured by bodyplethysmograph
Measured: day 1-3 and 17-19
energy expenditure during night assessed by Sensewear Armband
assessed by Sensewear Armband
Measured: day 5 and 15
quality of life
Short-Form-36 health survey, Hospital Anxiety and Depression scale and severe respiratory insufficiency questionnaire
Measured: day 1-3 and 17-19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionOct 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Noninvasive VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Schön Klinik Berchtesgadener Land
- Sponsor type
- University, hospital or other
- Collaborators
- Weinmann Geräte für Medizin GmbH + Co. KG
- Responsible party
- Principal investigator, Klaus Kenn, Schön Klinik Berchtesgadener Land
- Investigators
- Klaus Kenn, MD, Principal investigator, Schoen Klinik Berchtesgadener Land
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377739
- Sponsor's protocol ID
- NIV-ILD
- Status last verified
- Feb 2019
- First submitted
- 26 Feb 2015
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Ventilation in Patients With Interstitial Lung Disease - a Feasibility Study
- ClinicalTrials.gov ID
- NCT02377739
- Acronym / sponsor ID
- NIV-ILD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Schön Klinik Berchtesgadener LandUniversity, hospital or other
- Collaborators
- Weinmann Geräte für Medizin GmbH + Co. KG
- Study start
- Feb 2015 (actual)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 4 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non-invasive ventilation | Experimental | Other: non-invasive ventilationpatients will undergo about 14 nights of non-invasive ventilation during pulmonary rehabilitation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-invasive ventilationpatients will undergo a nocturnal non-invasive ventilation | Other | non-invasive ventilation |
Primary outcome
timespan until sufficient use of noninvasive ventilation > 6h during night
Time frame: day 4-16
5 secondary outcomes
6-minute walking test
Time frame: day 1-3 and day 17-19
arterial pressure of carbon dioxide during night
Time frame: day 1-3 and day 17-19
lung function measured by bodyplethysmograph
Time frame: day 1-3 and 17-19
energy expenditure during night assessed by Sensewear Armband
Time frame: day 5 and 15
quality of life
Time frame: day 1-3 and 17-19
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus Kenn, MD principal investigator
Schoen Klinik Berchtesgadener Land
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-invasive ventilation in people with Noninvasive Ventilation and Lung Diseases, Interstitial, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Klaus Kenn, MD (0049865293 ext. 1540, KKenn@Schoen-Kliniken.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
timespan until sufficient use of noninvasive ventilation > 6h during night (time frame: day 4-16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.