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

17. mars 2021 oppdatert av: Prof.dr. L.M.A. Heunks, Amsterdam UMC, location VUmc

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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Forventet)

40

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Nederland
    • Noord-Holland
      • Amsterdam, Noord-Holland, Nederland, 1081HV
        • Rekruttering
        • Amsterdam UMC, location VUmc
        • Ta kontakt med:
        • Underetterforsker:
          • Myrte Wennen, MSc
        • Hovedetterforsker:
          • Leo Heunks, Prof. Dr.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Patients that were recently (<= 7 days ago) discharged from the ICU and received mechanical ventilation form the study population with a specific sub group of COVID-19 patients. Healthy, age and gender matched volunteers are selected as control group.

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Healthy volunteers
Healthy volunteers, matched by age and gender to patient groups.
Annen: Contrast-enhanced MRI
Contrast-enhanced MRI
Annen: Measurement of respiratory muscle force
Measurement of the maximum inspiratory and expiratory pressure.
COVID-19 patients
Patients discharged from the ICU after invasive ventilation for COVID-19.
Annen: Contrast-enhanced MRI
Contrast-enhanced MRI
Annen: Measurement of respiratory muscle force
Measurement of the maximum inspiratory and expiratory pressure.
ICU patients
Patients discharged from the ICU after invasive ventilation for ARDS.
Annen: Contrast-enhanced MRI
Contrast-enhanced MRI
Annen: Measurement of respiratory muscle force
Measurement of the maximum inspiratory and expiratory pressure.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Tissue characteristics of the diaphragm
Tidsramme: 1 hour
Extracted from contrast enhanced imaging
1 hour
Movement of the diaphragm
Tidsramme: 1 hour
Description of the movement of the diaphragm in 4D fashion.
1 hour

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Quantitative dynamic contrast enhanced imaging of the diaphragm
Tidsramme: 1 hour
Application of modelling to describe tissue characteristics of the diaphragm using contrast inflow.
1 hour
Correlation of movement and tissue characteristics of the diaphragm with measurements of maximum inspiratory and expiratory pressure
Tidsramme: 1 hour
1 hour
Correlation of movement and tissue characteristics of the diaphragm with clinical parameters
Tidsramme: 1 hour
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.
1 hour

Andre resultatmål

Resultatmål
Tidsramme
Correlation of diaphragm tissue characteristics with tissue characteristics of the abdominal muscles
Tidsramme: 1 hour
1 hour

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Amsterdam UMC, location VUmc

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

3. februar 2021

Primær fullføring (Forventet)

19. januar 2023

Studiet fullført (Forventet)

19. januar 2023

Datoer for studieregistrering

Først innsendt

14. januar 2021

Først innsendt som oppfylte QC-kriteriene

2. februar 2021

Først lagt ut (Faktiske)

3. februar 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. mars 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. mars 2021

Sist bekreftet

1. mars 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NL 72271.029.19

Plan for individuelle deltakerdata (IPD)

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Nei

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