COPD With Hyperinflation Clinical Trial
Official title:
Upright Magnetic Resonance Imaging in COPD and Diaphragm Disease
| NCT number | NCT03531775 |
| Other study ID # | 18011 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | July 16, 2018 |
| Est. completion date | April 2020 |
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.
| Status | Recruiting |
| Enrollment | 80 |
| Est. completion date | April 2020 |
| Est. primary completion date | April 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 90 Years |
| Eligibility |
Inclusion Criteria: - General inclusion criteria: - Adult - Male or female, aged 18 to 90 years old - Capacity to give informed consent - Able to hold their breath for 10 seconds - Able to understand the requirements of the study and to cooperate with the study procedures - Cohort-specific inclusion criteria: Healthy participants - No reported or diagnosed chronic respiratory disease COPD with hyperinflation - Evidence of airflow obstruction on spirometry - FEV1/FVC < 0.7 and FEV1 <80%. (FEV1 = full expiratory volume in 1 second, FVC = full vital capacity) - Diagnosis of hyperinflation based on imaging or lung function measures. Diaphragm weakness due to non-neuromuscular disease - Established diagnosis of diaphragm weakness due to non-neuromuscular disease, e.g. viral illness, trauma. Diaphragm weakness due to neuromuscular disease - Established diagnosis of diaphragm weakness due to neuromuscular disease Exclusion Criteria: - Unsuitable for MRI scanning (e.g. have metal implants/pacemaker or contraindicated following questionnaire) - Deemed unlikely to comply with instructions during imaging - Deemed not fit enough to tolerate procedure - Deemed unsuitable by clinical investigator for other reasons - History of lung volume reduction procedure |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Nottingham University Hospitals NHS Trust | Nottingham | |
| United Kingdom | University of Nottingham | Nottingham |
| Lead Sponsor | Collaborator |
|---|---|
| University of Nottingham |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The diaphragm will be imaged using MRI in horizontal and vertical positions. | Images will be anonymised and stored securely on University servers. | 2 years | |
| Primary | The change in diaphragm position and morphology on MRI following a change in posture (vertical to horizontal position or vice versa) will be measured. | 2 years | ||
| Primary | The diaphragm position and morphology in COPD patients with hyperinflation will be imaged using MRI. | 2 years | ||
| Primary | The diaphragm position and morphology in patients known to have diaphragmatic weakness will be imaged using MRI. | 2 years | ||
| Secondary | The lung function abnormality will be compared with abnormalities in diaphragm position and morphology as noted on MRI. | 2 years | ||
| Secondary | The patients' symptoms, as reported on St George's Respiratory Questionnaire and a visual analogue scale for breathlessness, will be compared to the abnormalities noted in diaphragm position and morphology on MRI. | Participants will be asked to fill St George's Respiratory questionnaire and a visual analogue scale for breathlessness to assess symptoms. | 2 years |