Chronic Obstructive Pulmonary DiseaseNCT06163131
The Effect of Treatment of Emphysema With Endobronchial Valves on the Diaphragm Mobility
An observational study of Chronic Obstructive Pulmonary Disease and Emphysema or COPD, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
In some patients with chronic obstructive pulmonary disease (COPD) the breathlessness is caused by hyperinflation of the lungs. This causes difficulty breathing air out and makes it harder to breath in new air and limits the movement of the diaphram. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Emphysema or COPD
- How many people
- 35 participants
- Where
- 1 siteDenmark
- Study dates
- 27 Nov 2023to 1 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with COPD approved for treatment with endobronchial valves. The suitability will be assessed during multidiciplinary team conference, independent of this study.
Who may be able to join
- Patients selected to receive treatment with endobronchial valves
- Signed informed consent
Who cannot join
- Neuromuscular disease interfering with diaphragm function
- Pleural effusion at time of preoperative or 90-days postoperative ultrasound
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, 8200
Elisabeth Bendstrup, Professor, +45 7846 2201, karbends@rm.dk
About this study
In some patients with chronic obstructive pulmonary disease (COPD) the breathlessness is caused by hyperinflation of the lungs. This causes difficulty breathing air out and makes it harder to breath in new air and limits the movement of the diaphram. The diaphragm is the muscle used for breathing between the chest and the stomach. Some of these patients can receive treatment with endobronchial valves, where one-ways are inserted into the bronchial system the let out some of the excess air, and thereby relieve breathlessness.
The goal of this observational study is to investigate the effect of endobronchial valves on the mobility of the diaphragm in patients with chronic obstructive pulmonary disease. The main questions it aims to answer are:
Read more
- If the movement of the diaphragm improves after treatment with endobronchial valves.
- If there is a link between improvement of diaphragm function and improvement of symptoms, lung function and physical ability.
- If ultrasound scan immediately after the treatment will predict which patients will benefit from the treatment.
Participants will undergo ultrasound before, 1 day after and 90 days after the procedure, and lung function examinations from their already planned control visits will be collected.
Read the detailed description
When emphysema is present in COPD-patients, the impaired expiratory ventilation causes lung hyperinflation. This results in a change in the respiratory mechanisms of the thorax and thereby impairment of the movement capacity of the muscles. The most important respiratory muscle, the diaphragm, is caudally displaced and flattened, hence, the capacity and mobility of the muscle decreases.
Some patients with COPD fulfill the criteria for treatment with endobronchial valves (EBV) where one-way valves can be inserted in the bronchial system. The mechanism behind the effect of EBV is believed to be formation of an atelectasis of the designated lobe and thereby reduction of hyperinflation and hence reduction of symptoms and increase in pulmonary function
In this study the aim is to assess:
- If the movement of the diaphragm improves after insertion of endobronchial valves in patients with severe emphysema.
- If there is a correlation between improvement of diaphragm function and improvement of symptoms, lung function examinations and physical ability after insertion of endobronchial valves.
- If immediate post-procedural ultrasound evaluation of diaphragm function predicts the development of atelectasis and hence clinical outcome
- Keywords
- Ultrasound, Diaphragm, Endobronchial valves, Endobronchial Lung Volume Reduction
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | COPD patients treated with endobronchial valves. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragm mobility
The area method[13] will be used for assessment of diaphragm movement, using a curvilinear probe (2-6 MHz). Measurements will be performed during tidal respiration, deep respiration, sniff excursion and constant flow with constant volume, using test flute with bag of air attached.
Measured: Before the procedure, 1 day after the procedure and 90 days after the procedure
Diaphragm mobility
M-mode: Diaphragm excursion in tidal, deep and sniff inspiration will be evaluated in the right side using M-mode through anterior subcostal midclavicular view. Contraction and relaxation velocity will be measured.
Measured: Before the procedure, 1 day after the procedure and 90 days after the procedure
Diaphragm Thickening
Thickness and thickening ratio: The thickness and thickening ratio will be evaluated in B-mode using the linear probe, though lateral intercostal view during tidal respiration.
Measured: Before the procedure, 1 day after the procedure and 90 days after the procedure
Secondary outcomes (11)
Forced expiratory volume in 1 second in litres
Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments
Measured: Before and 90 days after the procedure
Forced expiratory volume in 1 second % of expected
Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments
Measured: Before and 90 days after the procedure
Forced vital capacity in litres
Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments
Measured: Before and 90 days after the procedure
Forced vital capacity in % of expected
Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments
Measured: Before and 90 days after the procedure
Total lung volume in % of expected
Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments
Measured: Before and 90 days after the procedure
Residual volume in % of expected
Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments
Measured: Before and 90 days after the procedure
diffusion capacity in % of expected
Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments
Measured: Before and 90 days after the procedure
6 Minute walking test
Patients will undergo 6 minutes walking test as a part of the independent preoperative and postoperative assessments
Measured: Before and 90 days after the procedure
Rate of atelectasis on Lung X-ray
Patients will receive x ray of the lungs as a part of the independent preoperative and postoperative assessments
Measured: Before, one day and 90 days after the procedure
Medical Research Council (MRC) Dyspnoea Scale
Medical Research Council (MRC) score will be used for symptom burden assessment
Measured: Before, one day and 90 days after the procedure
COPD Assessment Test (CAT) Score
CAT score will be used for symptom burden assessment
Measured: Before, one day and 90 days after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start27 Nov 2023 (estimated)
- Primary completion27 Nov 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirstine Hermann, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163131
- Sponsor's protocol ID
- KH02
- Status last verified
- Nov 2023
- First submitted
- 21 Nov 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Treatment of Emphysema With Endobronchial Valves on the Diaphragm Mobility
- ClinicalTrials.gov ID
- NCT06163131
- Acronym / sponsor ID
- KH02
- Keywords
- Ultrasound, Diaphragm, Endobronchial valves, Endobronchial Lung Volume Reduction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 27 Nov 2023 (estimated)
- Primary completion
- 27 Nov 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 8 Dec 2023 (actual)
- 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.
In some patients with chronic obstructive pulmonary disease (COPD) the breathlessness is caused by hyperinflation of the lungs. This causes difficulty breathing air out and makes it harder to breath in new air and limits the movement of the diaphram. The diaphragm is the muscle used for breathing between the chest and the stomach. Some of these patients can receive treatment with endobronchial valves, where one-ways are inserted into the bronchial system the let out some of the excess air, and thereby relieve breathlessness.
The goal of this observational study is to investigate the effect of endobronchial valves on the mobility of the diaphragm in patients with chronic obstructive pulmonary disease. The main questions it aims to answer are:
- If the movement of the diaphragm improves after treatment with endobronchial valves.
- If there is a link between improvement of diaphragm function and improvement of symptoms, lung function and physical ability.
- If ultrasound scan immediately after the treatment will predict which patients will benefit from the treatment.
Participants will undergo ultrasound before, 1 day after and 90 days after the procedure, and lung function examinations from their already planned control visits will be collected.
Detailed description
When emphysema is present in COPD-patients, the impaired expiratory ventilation causes lung hyperinflation. This results in a change in the respiratory mechanisms of the thorax and thereby impairment of the movement capacity of the muscles. The most important respiratory muscle, the diaphragm, is caudally displaced and flattened, hence, the capacity and mobility of the muscle decreases.
Some patients with COPD fulfill the criteria for treatment with endobronchial valves (EBV) where one-way valves can be inserted in the bronchial system. The mechanism behind the effect of EBV is believed to be formation of an atelectasis of the designated lobe and thereby reduction of hyperinflation and hence reduction of symptoms and increase in pulmonary function
In this study the aim is to assess:
- If the movement of the diaphragm improves after insertion of endobronchial valves in patients with severe emphysema.
- If there is a correlation between improvement of diaphragm function and improvement of symptoms, lung function examinations and physical ability after insertion of endobronchial valves.
- If immediate post-procedural ultrasound evaluation of diaphragm function predicts the development of atelectasis and hence clinical outcome
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –COPD patients treated with endobronchial valves. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with COPD approved for treatment with endobronchial valves. The suitability will be assessed during multidiciplinary team conference, independent of this study.
Key inclusion criteria (2 listed)
- Patients selected to receive treatment with endobronchial valves
- Signed informed consent
Key exclusion criteria (2 listed)
- Neuromuscular disease interfering with diaphragm function
- Pleural effusion at time of preoperative or 90-days postoperative ultrasound
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
Diaphragm mobility
Time frame: Before the procedure, 1 day after the procedure and 90 days after the procedure
The area method[13] will be used for assessment of diaphragm movement, using a curvilinear probe (2-6 MHz). Measurements will be performed during tidal respiration, deep respiration, sniff excursion and constant flow with constant volume, using test flute with bag of air attached.
Diaphragm mobility
Time frame: Before the procedure, 1 day after the procedure and 90 days after the procedure
M-mode: Diaphragm excursion in tidal, deep and sniff inspiration will be evaluated in the right side using M-mode through anterior subcostal midclavicular view. Contraction and relaxation velocity will be measured.
Diaphragm Thickening
Time frame: Before the procedure, 1 day after the procedure and 90 days after the procedure
Thickness and thickening ratio: The thickness and thickening ratio will be evaluated in B-mode using the linear probe, though lateral intercostal view during tidal respiration.
11 secondary outcomes
Forced expiratory volume in 1 second in litres
Time frame: Before and 90 days after the procedure
Forced expiratory volume in 1 second % of expected
Time frame: Before and 90 days after the procedure
Forced vital capacity in litres
Time frame: Before and 90 days after the procedure
Forced vital capacity in % of expected
Time frame: Before and 90 days after the procedure
Total lung volume in % of expected
Time frame: Before and 90 days after the procedure
Residual volume in % of expected
Time frame: Before and 90 days after the procedure
diffusion capacity in % of expected
Time frame: Before and 90 days after the procedure
6 Minute walking test
Time frame: Before and 90 days after the procedure
Rate of atelectasis on Lung X-ray
Time frame: Before, one day and 90 days after the procedure
Medical Research Council (MRC) Dyspnoea Scale
Time frame: Before, one day and 90 days after the procedure
COPD Assessment Test (CAT) Score
Time frame: Before, one day and 90 days after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Emphysema or COPD, run by Aarhus University Hospital at 1 site in Denmark.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 8 Dec 2023. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragm mobility (time frame: Before the procedure, 1 day after the procedure and 90 days after the procedure). The study lists 3 primary outcomes in all. 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 8 Dec 2023.