COPD With Hyperinflation Clinical Trial
Official title:
Upright Magnetic Resonance Imaging in COPD and Diaphragm Disease
The diaphragm is the main muscle assisting breathing. This study aims to assess the use of
MRI in patients with diaphragmatic weakness and patients with Chronic Obstructive Pulmonary
Disease (COPD) who have hyperinflation. In some patients with COPD, air gets trapped in the
lungs and causes them to expand too much; this is called hyperinflation. These patient report
severe breathlessness, which may be in part because of their diaphragm. It is known that
posture impacts lung function and breathing and the investigators want to assess the effect
of posture on the diaphragm. Currently, lung function tests and CT or ultrasound scan are the
main tests used to check how the diaphragm works. Recently, at University of Nottingham, an
new imaging approach has been developed that uses an upright MRI allowing testing the
patients in lying position and seated/standing in the same scanner. This may help researchers
test the diaphragm position and shape more accurately and check the effects of posture on the
diaphragm. This may help researchers and clinicians better understand the relationship
between postural changes in diaphragm position and shape and symptoms.
The study will take place at the clinical research MRI centre at Nottingham Medical School,
which is next to Queen's Medical Centre. The investigators want to recruit healthy
volunteers, patients with diaphragmatic weakness and patients with COPD whose lungs are
hyperinflated. The study will last 2 years, and the participants are asked to attend the
imaging centre only once, where they will give consent and will be scanned at the same visit,
which is expected to take 2 hours to complete. They will be scanned on two scanners: lying
and seated/standing in the new upright scanner and lying in a conventional scanner. The
investigators will not use any contrast for imaging, i.e. participants will not be injected
with a dye and they will breathe air.
This is a single centre, proof of concept clinical trial. The investigators want to recruit
healthy volunteers, patients with diaphragmatic weakness and patients with COPD whose lungs
are hyperinflated. Half the investigators are clinicians and have asked their patient whether
such a study would interest them, and patients have been very supportive. This study
addresses an unanswered clinical question.
The participants will be adults, men and women, who can give informed consent, and can
cooperate with the study procedures. As the participants will be scanned using MRI, people
who are unsuitable for MRI scanning, for example those with a pacemaker, will be excluded
from the study for safety reasons.The participant will be observed by a clinical investigator
throughout the study visit.
As for side effects / risks, no medicinal products will be administered in this study. Some
participants may experience anxiety while undergoing MRI scan. It is expected that some
patients may not be able to lie flat in the scanner, in which case they will be asked only to
undergo scans that they are able to tolerate.
In addition to being scanned using an upright MRI and a conventional MRI, the following
measurements will be takes: weight, height, blood pressure, heart rate, oxygen saturation,
respiratory rate, and spirometry. The participants will be asked to fill a St George's
Respiratory Questionnaire and an MRC (Medical Research Council) Dyspnoea Scale. A detailed
medical history will be taken.
The participants will be assigned unique codes, and their data will be anonymised.
Participants' medical reports will only be accessed for study purposes and will be treated as
confidential.
The investigators will aim to use the data to plan future studies, and the data from this
study may contribute to publications and presentations. Participants will not be identified
in any publications arising from the research. The data obtained will be published without
any identifying information..
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