Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT04735757
Eligibility Criteria:
Inclusion criteria
In order to be eligible to participate in this study, a subject in the case group must meet all of the following criteria:
* Invasive mechanical ventilation \> 72 hours during current hospital admission
* Admitted for COVID-19-infection (n = 10)
* Currently negative COVID-19 PCR test
* Discharged from the ICU ≤ 7 days ago
* Signed informed consent
* Age ≥ 18 years
In order to be eligible to participate in this study, a subject in the control group must meet all of the following criteria:
* Signed informed consent
* Age ≥ 18 years
* Similar age (max 5 years difference) and gender of one of the subjects in case group
Exclusion criteria
A potential subject for the case group who meets any of the following criteria will be excluded from participation in this study:
* Known history of:
* Diaphragmatic injury or weakness prior to ICU stay
* COPD (GOLD IV)
* Neuromuscular disease (including pathology of the n. phrenicus)
* Connective tissue disease
* Chronic use of corticosteroids (\>7.5 mg/day for at least 3 months before hospital admission)
* \>10% weight loss within last 6 months prior to ICU admission
* Obesity (BMI \> 30 kg/m2 at hospital admission)
* Known pregnancy
* Contraindications for MRI
* Electrical/metallic implants
* Claustrophobia
* Unable to hold breath for 10 seconds
* Hierarchical relation with one of the collaborating investigators
* Incapacitation
* Contraindications for the use of a Gadolinium based contrast agent for MRI
* Known eGFR \< 30 ml/min/1.73m2
* Known history of allergic reactions to an MRI contrast medium
* Known history of allergic reactions requiring immediate treatment
* Known history of atopy
* Asthma These exclusion criteria are based on the guidelines for contrast agents from the European Society for Urogenital Radiology (http://www.esur.org/guidelines/).
Additional exclusion criteria for the case group, subset non-infected patients are:
• History of COVID-19-infection (confirmed with positive test)
Additional exclusion criteria for the control group are:
* History of mechanical ventilation \> 24 hours
* History of COVID-19-infection (confirmed with positive test)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04735757
Study Brief:
Protocol Section:
NCT04735757