Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06163131
Status:
RECRUITING
Last Update Posted:
2023-12-08
First Post:
2023-11-21
Brief Title:
The Effect of Treatment of Emphysema With Endobronchial Valves on the Diaphragm Mobility
Sponsor:
Aarhus University Hospital
Organization:
Aarhus University Hospital
Study Overview
Official Title:
The Effect of Treatment of Emphysema With Endobronchial Valves on the Diaphragm Mobility
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None