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NCT Number: NCT06163131

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Emphysema Emphysema or COPD Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital

Aarhus, 8200, Denmark

Location status: Recruiting

Location contact

Elisabeth Bendstrup, Professor

CONTACT

[email protected]

+45 7846 2201

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients selected to receive treatment with endobronchial valves
  • Signed informed consent

Exclusion criteria

  • Neuromuscular disease interfering with diaphragm function
  • Pleural effusion at time of preoperative or 90-days postoperative ultrasound

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Forced expiratory volume in 1 second in litres

    Time frame: Before and 90 days after the procedure

    Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments

  2. Forced expiratory volume in 1 second % of expected

    Time frame: Before and 90 days after the procedure

    Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments

  3. Forced vital capacity in litres

    Time frame: Before and 90 days after the procedure

    Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments

  4. Forced vital capacity in % of expected

    Time frame: Before and 90 days after the procedure

    Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments

  5. Total lung volume in % of expected

    Time frame: Before and 90 days after the procedure

    Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments

  6. Residual volume in % of expected

    Time frame: Before and 90 days after the procedure

    Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments

  7. diffusion capacity in % of expected

    Time frame: Before and 90 days after the procedure

    Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments

  8. 6 Minute walking test

    Time frame: Before and 90 days after the procedure

    Patients will undergo 6 minutes walking test as a part of the independent preoperative and postoperative assessments

  9. Rate of atelectasis on Lung X-ray

    Time frame: Before, one day and 90 days after the procedure

    Patients will receive x ray of the lungs as a part of the independent preoperative and postoperative assessments

  10. Medical Research Council (MRC) Dyspnoea Scale

    Time frame: Before, one day and 90 days after the procedure

    Medical Research Council (MRC) score will be used for symptom burden assessment

  11. COPD Assessment Test (CAT) Score

    Time frame: Before, one day and 90 days after the procedure

    CAT score will be used for symptom burden assessment

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Dec 8, 2023
Registry last updated
Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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