The Effect of Treatment of Emphysema With Endobronchial Valves on the Diaphragm Mobility
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAarhus University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients selected to receive treatment with endobronchial valves
Signed informed consent
Disqualifiers
Neuromuscular disease interfering with diaphragm function
Pleural effusion at time of preoperative or 90-days postoperative ultrasound
Trial population
Patients with COPD approved for treatment with endobronchial valves. The suitability will be assessed during multidiciplinary team conference, independent of this study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
35 Participants
are grouped into 1 trial groupGroup A: Patients
Trial outcomes
Primary outcomes
1
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.
Time frame
Before the procedure, 1 day after the procedure and 90 days after the procedure2
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.
Time frame
Before the procedure, 1 day after the procedure and 90 days after the procedure3
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.
Time frame
Before the procedure, 1 day after the procedure and 90 days after the procedureSecondary outcomes
1
Forced expiratory volume in 1 second in litres
Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments
Time frame
Before and 90 days after the procedure2
Forced expiratory volume in 1 second % of expected
Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments
Time frame
Before and 90 days after the procedure3
Forced vital capacity in litres
Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments
Time frame
Before and 90 days after the procedure4
Forced vital capacity in % of expected
Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments
Time frame
Before and 90 days after the procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov