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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease; Emphysema or COPD

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:

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

• Study Type: Observational
• Enrollment (Estimated): 35

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Recruiting
    • Aarhus University Hospital
    • Contact: Elisabeth Bendstrup, Professor; Phone Number: +45 7846 2201; Email: karbends@rm.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with COPD approved for treatment with endobronchial valves. The suitability will be assessed during multidiciplinary team conference, independent of this study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients; COPD patients treated with endobronchial valves.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
COPD Assessment Test (CAT) Score	CAT score will be used for symptom burden assessment	Before, one day and 90 days after the procedure

Collaborators and Investigators

• Sponsor: Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): November 27, 2023
• Primary Completion (Estimated): November 27, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: November 21, 2023
• First Submitted That Met QC Criteria: November 30, 2023
• First Posted (Actual): December 8, 2023

Study Record Updates

• Last Update Posted (Actual): December 8, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Ultrasound; Diaphragm; Endobronchial valves; Endobronchial Lung Volume Reduction
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Chronic Disease; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: KH02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No