Effects of COVID-19-infection on movement and tissue characteristics of the diaphragm visualized by magnetic resonance imaging: a proof-of-concept study

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

Invasive mechanical ventilation > 72 hours during current hospital admission
(only patients)

Discharged from the ICU <= 14 days ago (only patients)

Admitted for COVID-19-infection (n = 10)

Currently negative COVID-19 PCR test (only previously infected subjects)

Age 50-70 years (only healthy volunteers)

Signed informed consent

Age >= 18 years (only patients)

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• Known history of:
o Diaphragmatic injury or weakness
o COPD (GOLD IV)
o Neuromuscular disease (including pathology of the n. phrenicus)
o Connective tissue disease
o Chronic use of corticosteroids (>7.5 mg/day for at least 3 months before
hospital admission)
o >10% weight loss within last 6 months (before hospital admission)
o COVID-19-infection, confirmed with positive test (except for subset of
infected patients)

• Known pregnancy

• Contraindications for MRI
o Electrical/metallic implants
o Claustrophobia

• Hierarchical relation with one of the collaborating investigators

• Incapacitation

• Contraindications for the use of a Gadolinium based contrast agent for MRI
o eGFR < 30 ml/min/1.73m2
o Known history of allergic reactions to a MRI contrast medium
o Known history of atopy
o Unstable Asthma

Additional exclusion criteria for the control group are:
• History of mechanical ventilation > 24 hours

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters are the configuration of the diaphragm and chest wall<br /><br>during tidal breathing and tissue characteristics (amount of fat and/or water<br /><br>infiltration, presence of fibrosis or inflammation) of the diaphragm. Secondary<br /><br>parameters include function of the diaphragm, quantified by mean inspiratory<br /><br>and expiratory pressure and clinical parameters such as mode and duration of<br /><br>ventilation and inflammatory markers. The primary study parameters (MRI<br /><br>measurements) will be compared between case and control group and tested for<br /><br>correlation with secondary outcomes. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. To relate the primary study parameters to clinical parameters, such as mode<br /><br>and duration of mechanical ventilation and inflammatory parameters.<br /><br>2. To relate the primary study parameters to respiratory muscle function,<br /><br>namely maximum inspiratory (MIP) and expiratory pressure (MEP).<br /><br>3. To relate the primary study parameters to thickness and intensity of the<br /><br>muscle on ultrasound images</p><br>