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
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
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Noord-Holland
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Amsterdam, Noord-Holland, Nederländerna, 1081HV
- Rekrytering
- Amsterdam UMC, location VUMC
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Kontakt:
- Myrte Wennen, MSc
- Telefonnummer: (020) 444 4444
- E-post: m.wennen@amsterdamumc.nl
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Underutredare:
- Myrte Wennen, MSc
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Huvudutredare:
- Leo Heunks, Prof. Dr.
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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)
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
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Healthy volunteers
Healthy volunteers, matched by age and gender to patient groups.
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Contrast-enhanced MRI
Measurement of the maximum inspiratory and expiratory pressure.
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COVID-19 patients
Patients discharged from the ICU after invasive ventilation for COVID-19.
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Contrast-enhanced MRI
Measurement of the maximum inspiratory and expiratory pressure.
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ICU patients
Patients discharged from the ICU after invasive ventilation for ARDS.
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Contrast-enhanced MRI
Measurement of the maximum inspiratory and expiratory pressure.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Tissue characteristics of the diaphragm
Tidsram: 1 hour
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Extracted from contrast enhanced imaging
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1 hour
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Movement of the diaphragm
Tidsram: 1 hour
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Description of the movement of the diaphragm in 4D fashion.
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1 hour
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Quantitative dynamic contrast enhanced imaging of the diaphragm
Tidsram: 1 hour
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Application of modelling to describe tissue characteristics of the diaphragm using contrast inflow.
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1 hour
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Correlation of movement and tissue characteristics of the diaphragm with measurements of maximum inspiratory and expiratory pressure
Tidsram: 1 hour
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1 hour
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Correlation of movement and tissue characteristics of the diaphragm with clinical parameters
Tidsram: 1 hour
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Clinical 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.
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1 hour
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Andra resultatmått
Resultatmått |
Tidsram |
|---|---|
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Correlation of diaphragm tissue characteristics with tissue characteristics of the abdominal muscles
Tidsram: 1 hour
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1 hour
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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NL 72271.029.19
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