The Effect of Treatment of Emphysema With Endobronchial Valves on the Diaphragm Mobility

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

The Effect of Treatment of Emphysema With Endobronchial Valves on the Diaphragm Mobility

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06163131
• Other study ID #: KH02
• Status: Recruiting
• Start date: November 27, 2023
• Est. completion date: April 1, 2027

Study information

• Verified date: November 2023
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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:

1. If the movement of the diaphragm improves after insertion of endobronchial valves in patients with severe emphysema.

2. 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.

3. If immediate post-procedural ultrasound evaluation of diaphragm function predicts the development of atelectasis and hence clinical outcome

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: April 1, 2027
• Est. primary completion date: November 27, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients selected to receive treatment with endobronchial valves

2. Signed informed consent

Exclusion Criteria:

1. Neuromuscular disease interfering with diaphragm function

2. Pleural effusion at time of preoperative or 90-days postoperative ultrasound

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Emphysema
• Emphysema or COPD
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Emphysema

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Before the procedure, 1 day after the procedure and 90 days after the procedure
Primary	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.	Before the procedure, 1 day after the procedure and 90 days after the procedure
Primary	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.	Before the procedure, 1 day after the procedure and 90 days after the procedure
Secondary	Forced expiratory volume in 1 second in litres	Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments	Before and 90 days after the procedure
Secondary	Forced expiratory volume in 1 second % of expected	Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments	Before and 90 days after the procedure
Secondary	Forced vital capacity in litres	Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments	Before and 90 days after the procedure
Secondary	Forced vital capacity in % of expected	Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments	Before and 90 days after the procedure
Secondary	Total lung volume in % of expected	Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments	Before and 90 days after the procedure
Secondary	Residual volume in % of expected	Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments	Before and 90 days after the procedure
Secondary	diffusion capacity in % of expected	Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments	Before and 90 days after the procedure
Secondary	6 Minute walking test	Patients will undergo 6 minutes walking test as a part of the independent preoperative and postoperative assessments	Before and 90 days after the procedure
Secondary	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	Before, one day and 90 days after the procedure
Secondary	Medical Research Council (MRC) Dyspnoea Scale	Medical Research Council (MRC) score will be used for symptom burden assessment	Before, one day and 90 days after the procedure
Secondary	COPD Assessment Test (CAT) Score	CAT score will be used for symptom burden assessment	Before, one day and 90 days after the procedure