pright MRI in lung disease

Not Applicable

Completed

• Conditions: Diaphragmatic weakness or COPD (chronic obstructive pulmonary disease) with hyperinflation; Respiratory

• Registration Number: ISRCTN15470049
• Lead Sponsor: niversity of Nottingham

Brief Summary

2021 results in https://pubmed.ncbi.nlm.nih.gov/32739780/ (added 10/05/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-23
• Study Completion: 2020-04-30
• Last Update Posted: 24 May 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Healthy volunteers and patients with diaphragm weakness (due to neuromuscular disease, e.g. motor neuron disease, and non-neuromuscular disease e.g. trauma) and patient with COPD with hyperinflation

General inclusion criteria:
1. Adult - male or female, aged 18 to 90 years old
2. Capacity to give informed consent
3. Able to hold their breath for 10 seconds
4. Able to understand the requirements of the study and to cooperate with the study procedures

Cohort-specific inclusion criteria:

Healthy participants:
1. No reported or diagnosed chronic respiratory disease

COPD with hyperinflation:
1. Evidence of airflow obstruction on spirometry – FEV1/FVC < 0.7 and FEV1 <80%
2. Diagnosis of hyperinflation based on imaging or lung function measures

Diaphragm weakness due to non-neuromuscular disease:
1. Established diagnosis of diaphragm weakness due to non-neuromuscular disease, e.g. viral illness, trauma

Diaphragm weakness due to neuromuscular disease:
1. Established diagnosis of diaphragm weakness due to neuromuscular disease

Exclusion Criteria

1. Unsuitable for MRI scanning (e.g. have metal implants or pacemaker or contraindicated following questionnaire)
2. Deemed unlikely to comply with instructions during imaging
3. Deemed not fit enough to tolerate procedure
4. Deemed unsuitable by clinical investigator for other reasons
5. History of lung volume reduction procedure

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Change in diaphragm position and morphology caused by a change in posture (vertical to horizontal position or vice versa), measured by analysis of MR images once during the one scan visit. Analysis is performed using Matlab software<br> 2. Degree of impairment in diaphragm movement in COPD patients with hyperinflation, measured once during the one scan visit. Analysis is performed using Matlab software. Patient scans are compared to healthy volunteer scans<br> 3. Correlation between lung function abnormality with abnormalities in diaphragm movement as noted on MRI. Spirometry and scan are performed on the same day during the scan visit<br>

Secondary Outcome Measures

Name	Time	Method
Tolerability data on the ability of participants of each group to adhere to the protocol thus informing the study design of future trials. Participants are asked to fill a visual analogue scale for breathless comparing the severity of breathless in lying and seated positions, right after completing the scans