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Effects of COVID-19 Infection and Critical Illness on Diaphragm Tissue Characteristics and Movement, Visualized With MRI

Effects of COVID-19-infection and Mechanical Ventilation on Movement and Tissue Characteristics of the Diaphragm, Visualized by Magnetic Resonance Imaging: a Proof-of-concept Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04735757
Enrollment
40
Registered
2021-02-03
Start date
2021-02-03
Completion date
2023-01-19
Last updated
2021-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, Diaphragm Disease

Keywords

MRI, Mechanical ventilation, Diaphragm

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, difficult weaning and increased mortality. Our research group recently found evidence for fibrosis and expression of genes involved in fibrosis as well as viral infiltration of the SARS-CoV-2 virus in diaphragm biopsies from COVID-19 ICU patients. This finding suggests a unique manifestation of diaphragm injury in COVID-19 patients after mechanical ventilation. However, it remains unclear what the exact nature and location of diaphragm injury is. Additionally, it is largely unknown whether this injury affects the movement of the diaphragm, but this might have important clinical implications. Therefore, we aim at visualizing the tissue characteristics and movement of the diaphragm in COVID-19 patients who recently received long-term mechanical ventilation, other ICU patients and healthy controls, using magnetic resonance imaging (MRI). MRI of the diaphragm was already shown feasible in previous research from our group (article currently under review). New insights in the characteristics of diaphragm weakness and injury in COVID-19 patients and control ICU-patients will contribute to strategies to prevent it and monitor the diaphragm of patients under mechanical ventilation, which can contribute to better patient outcomes.

Interventions

Contrast-enhanced MRI

OTHERMeasurement of respiratory muscle force

Measurement of the maximum inspiratory and expiratory pressure.

Sponsors

Amsterdam UMC, location VUmc
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Tissue characteristics of the diaphragm1 hourExtracted from contrast enhanced imaging
Movement of the diaphragm1 hourDescription of the movement of the diaphragm in 4D fashion.

Secondary

MeasureTime frameDescription
Quantitative dynamic contrast enhanced imaging of the diaphragm1 hourApplication of modelling to describe tissue characteristics of the diaphragm using contrast inflow.
Correlation of movement and tissue characteristics of the diaphragm with measurements of maximum inspiratory and expiratory pressure1 hour
Correlation of movement and tissue characteristics of the diaphragm with clinical parameters1 hourClinical parameters include ventilator settings, biomarkers for inflammation (CRP, white blood cell count) during ICU admission, daily dosage of drugs known with adverse effects on respiratory muscles, fluid balance, protein intake, primary reason for ICU admission and weaning duration.

Other

MeasureTime frame
Correlation of diaphragm tissue characteristics with tissue characteristics of the abdominal muscles1 hour

Countries

Netherlands

Contacts

Primary ContactLeo Heunks, Prof. Dr.
l.heunks@amsterdamumc.nl(020) 444 4444

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026