Obstructive Chronic BronchitisNCT02942134
Acute Dyspnea After Use of Non-invasive Ventilation in COPD and Emphysema (Deventilation Syndrome)
An observational study of Obstructive Chronic Bronchitis, run by Felix JF Herth.
Trial summary
Acute dyspnea after use of non-invasive ventilation (NIV) is a common phenomenon in patients with COPD and emphysema. This trial aims to document incidence and severity of augmented dyspnea in patients with long term NIV therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obstructive Chronic Bronchitis
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to May 2018
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic hypercapnic failure due to COPD III to IV GOLD and emphysema on long term noninvasive ventilation
Who may be able to join
- Males and females with stabile COPD, last exacerbation over one month,
- GOLD III to IV
- Regular use of noninvasive ventilation, more than four hours per day for more than one year
- Signed declaration of consent
- Sufficient language capabilities, german
Who cannot join
- Acute exacerbation in the past four weeks
- Acute pulmonary embolus
- Haemoptysis
- Severe neurological disease
- Severe cardiological disease
- Haemodynamic instability
Show all 12Show fewer
- New hypoxia or worsening of hypercapnia more than twenty percent of usual rate
- Acute pneumothorax
- Other instable Situation, for example intraabdominal bleedings
- Drug or alcohol dependency
- Regular intake of morphium
- Adiposity BMI over 35
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Acquisition and Evaluation of Augemented Dyspnea After Use of Non-invasive Ventilation in Patients With COPD and Empysema (Deventilation Syndrome)
Acute dyspnea after use of non-invasive ventilation (NIV) is a common phenomenon in patients with COPD and emphysema. This trial aims to document incidence and severity of augmented dyspnea in patients with long term NIV therapy. These findings may help in understanding the pathomechanisms that lead to post-NIV dyspnea and thus give way to potential therapy schemes.
Read the detailed description
Non-invasive ventilation (NIV) is a widespread therapy option for patients with hypercapnic failure due to COPD and emphysema. Augmented dyspnea after use of NIV is commonly found and leads not only to high patient discomfort, but can also be associated with acute respiratory failure. This monocentric obervation trial includes patients with COPD III°-IV° (GOLD) and emphysema and an established long term NIV therapy. During their routine inpatient follow-up, we will extend the routine examinations, focussing on the vulnerable first hour after the nocturnal use of NIV. This includes monitoring of breath rate, heart rate, pulsoxymetry, trancutaneous CO2, blood pressure and capillary blood gas analysis. Sonographic measurement of diaphragm movement and thickness will be complemented. Subjective dyspnea will be documented by use of the BORG scale.
By collecting this data, we hope to understand the pathomechanisms causing augmented dyspnea after NIV and thus provide information for therapeutical concepts to prevent it.
- Conditions
- Obstructive Chronic Bronchitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of acute dyspnea after use of non-invasive Ventilation in COPD and emphysema
Measured: May 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionOct 2017 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Chronic BronchitisStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Felix JF Herth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Felix JF Herth, Heidelberg University
- Investigators
- Felix FJ Herth, Prof., Principal investigator, Medical Director Thoraxklinik Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942134
- Sponsor's protocol ID
- S-484/2016
- Status last verified
- Oct 2016
- First submitted
- 20 Oct 2016
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acquisition and Evaluation of Augemented Dyspnea After Use of Non-invasive Ventilation in Patients With COPD and Empysema (Deventilation Syndrome)
- ClinicalTrials.gov ID
- NCT02942134
- Acronym / sponsor ID
- S-484/2016
- Conditions
- Obstructive Chronic Bronchitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Felix JF HerthUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 21 Oct 2016 (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.
Acute dyspnea after use of non-invasive ventilation (NIV) is a common phenomenon in patients with COPD and emphysema. This trial aims to document incidence and severity of augmented dyspnea in patients with long term NIV therapy. These findings may help in understanding the pathomechanisms that lead to post-NIV dyspnea and thus give way to potential therapy schemes.
Detailed description
Non-invasive ventilation (NIV) is a widespread therapy option for patients with hypercapnic failure due to COPD and emphysema. Augmented dyspnea after use of NIV is commonly found and leads not only to high patient discomfort, but can also be associated with acute respiratory failure. This monocentric obervation trial includes patients with COPD III°-IV° (GOLD) and emphysema and an established long term NIV therapy. During their routine inpatient follow-up, we will extend the routine examinations, focussing on the vulnerable first hour after the nocturnal use of NIV. This includes monitoring of breath rate, heart rate, pulsoxymetry, trancutaneous CO2, blood pressure and capillary blood gas analysis. Sonographic measurement of diaphragm movement and thickness will be complemented. Subjective dyspnea will be documented by use of the BORG scale.
By collecting this data, we hope to understand the pathomechanisms causing augmented dyspnea after NIV and thus provide information for therapeutical concepts to prevent it.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic hypercapnic failure due to COPD III to IV GOLD and emphysema on long term noninvasive ventilation
Key inclusion criteria (5 listed)
- Males and females with stabile COPD, last exacerbation over one month,
- GOLD III to IV
- Regular use of noninvasive ventilation, more than four hours per day for more than one year
- Signed declaration of consent
- Sufficient language capabilities, german
Key exclusion criteria (12 listed)
- Acute exacerbation in the past four weeks
- Acute pulmonary embolus
- Haemoptysis
- Severe neurological disease
- Severe cardiological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence and severity of acute dyspnea after use of non-invasive Ventilation in COPD and emphysema
Time frame: May 2018
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Felix FJ Herth, Prof. principal investigator
Medical Director Thoraxklinik Heidelberg
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Chronic Bronchitis, run by Felix JF Herth.
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 5 inclusion and 12 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 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Mavi D Schellenberg, Dr.med. (00496221-3968027, mavi.schellenberg@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of acute dyspnea after use of non-invasive Ventilation in COPD and emphysema (time frame: May 2018). 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 21 Oct 2016.