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

NCT ID: NCT04735757

Last Updated: 2021-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-03
• Study Completion Date: 2023-01-19

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.

Conditions

Diaphragm Disease; Covid19

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy volunteers

Healthy volunteers, matched by age and gender to patient groups.

Contrast-enhanced MRI

Intervention Type: OTHER

Contrast-enhanced MRI

Measurement of respiratory muscle force

Intervention Type: OTHER

Measurement of the maximum inspiratory and expiratory pressure.

COVID-19 patients

Patients discharged from the ICU after invasive ventilation for COVID-19.

Contrast-enhanced MRI

Intervention Type: OTHER

Contrast-enhanced MRI

Measurement of respiratory muscle force

Intervention Type: OTHER

Measurement of the maximum inspiratory and expiratory pressure.

ICU patients

Patients discharged from the ICU after invasive ventilation for ARDS.

Contrast-enhanced MRI

Intervention Type: OTHER

Contrast-enhanced MRI

Measurement of respiratory muscle force

Intervention Type: OTHER

Measurement of the maximum inspiratory and expiratory pressure.

Interventions

Contrast-enhanced MRI

Contrast-enhanced MRI

Intervention Type: OTHER

Measurement of respiratory muscle force

Measurement of the maximum inspiratory and expiratory pressure.

Intervention Type: OTHER

Eligibility Criteria

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

• History of COVID-19-infection (confirmed with positive test)

• History of mechanical ventilation > 24 hours
• History of COVID-19-infection (confirmed with positive test)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Amsterdam UMC, location VUmc

OTHER

Sponsor Role: lead

Responsible Party

Prof.dr. L.M.A. Heunks

Professor Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Amsterdam UMC, location VUmc

Amsterdam, North Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Leo Heunks, Prof. Dr.

Role: CONTACT

l.heunks@amsterdamumc.nl

(020) 444 4444

Facility Contacts

Myrte Wennen, MSc

Role: primary

m.wennen@amsterdamumc.nl

(020) 444 4444

Other Identifiers

NL 72271.029.19

Identifier Type: -

Identifier Source: org_study_id