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Clinical Trials/NCT04735757
NCT04735757
Unknown
Not Applicable

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

Amsterdam UMC, location VUmc1 site in 1 country40 target enrollmentFebruary 3, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diaphragm Disease
Sponsor
Amsterdam UMC, location VUmc
Enrollment
40
Locations
1
Primary Endpoint
Tissue characteristics of the diaphragm
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 3, 2021
End Date
January 19, 2023
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Amsterdam UMC, location VUmc
Responsible Party
Principal Investigator
Principal Investigator

Prof.dr. L.M.A. Heunks

Professor Doctor

Amsterdam UMC, location VUmc

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Tissue characteristics of the diaphragm

Time Frame: 1 hour

Extracted from contrast enhanced imaging

Movement of the diaphragm

Time Frame: 1 hour

Description of the movement of the diaphragm in 4D fashion.

Secondary Outcomes

  • Quantitative dynamic contrast enhanced imaging of the diaphragm(1 hour)
  • Correlation of movement and tissue characteristics of the diaphragm with measurements of maximum inspiratory and expiratory pressure(1 hour)
  • Correlation of movement and tissue characteristics of the diaphragm with clinical parameters(1 hour)

Study Sites (1)

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