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

• Conditions: Covid19; Diaphragm Disease

• Registration Number: NCT04735757
• Lead Sponsor: Amsterdam UMC, location VUmc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-14
• Study First Submitted QC: 2021-02-02
• Study Start: 2021-02-03
• Study First Posted: 2021-02-03
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-17
• Last Update Posted: 2021-03-18
• Primary Completion: 2023-01-19
• Study Completion: 2023-01-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tissue characteristics of the diaphragm	1 hour	Extracted from contrast enhanced imaging
Movement of the diaphragm	1 hour	Description of the movement of the diaphragm in 4D fashion.

Secondary Outcome Measures

Name	Time	Method
Quantitative dynamic contrast enhanced imaging of the diaphragm	1 hour	Application 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 pressure	1 hour
Correlation of movement and tissue characteristics of the diaphragm with clinical parameters	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.

Trial Locations

Locations (1)

Amsterdam UMC, location VUmc; 🇳🇱 Amsterdam, Noord-Holland, Netherlands