Status:
UNKNOWN
Effects of COVID-19 Infection and Critical Illness on Diaphragm Tissue Characteristics and Movement, Visualized With MRI
Lead Sponsor:
Amsterdam UMC, location VUmc
Conditions:
Diaphragm Disease
Covid19
Eligibility:
All Genders
18+ years
Brief Summary
COVID-19-infection has a large impact on the respiratory system and possibly on the diaphragm, the main respiratory muscle. In ICU-patients, diaphragm weakness is associated with prolonged ICU-stay, d...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
February 3 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 19 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04735757
Start Date
February 3 2021
End Date
January 19 2023
Last Update
March 18 2021
Active Locations (1)
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1
Amsterdam UMC, location VUmc
Amsterdam, North Holland, Netherlands, 1081HV