SARS-CoV-19-infection associated diaphragm weakness
Conditions
Interventions
MRI measurements will be performed for every subject. In the case group, also a 
contrast agent (Dotarem ® 0.5 mmol) will be used to enhance visualization of 
the diaphragm. Next to that, subjects are asked to perform manoeuvres to 
determine the maximum inspiratory and expiratory pressure for every subject.
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameters are the configuration of the diaphragm and chest wall during tidal breathing and tissue characteristics (amount of fat and/or water infiltration, presence of fibrosis or inflammation) of the diaphragm. Secondary parameters include function of the diaphragm, quantified by mean inspiratory and expiratory pressure and clinical parameters such as mode and duration of ventilation and inflammatory markers. The primary study parameters (MRI measurements) will be compared between case and control group and tested for correlation with secondary outcomes. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To relate the primary study parameters to clinical parameters, such as mode and duration of mechanical ventilation and inflammatory parameters. 2. To relate the primary study parameters to respiratory muscle function, namely maximum inspiratory (MIP) and expiratory pressure (MEP). 3. To relate the primary study parameters to thickness and intensity of the muscle on ultrasound images | — |
Countries
Netherlands
Outcome results
None listed