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

NCT04735757 | Unknown

• 1 other identifier: NL 72271.029.19
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

MRI; Mechanical ventilation; Diaphragm

Outcome Measures

Primary Outcomes (2)

• Tissue characteristics of the diaphragm

  Extracted from contrast enhanced imaging

  1 hour

• Movement of the diaphragm

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

  1 hour

Secondary Outcomes (3)

• 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

Other Outcomes (1)

• Correlation of diaphragm tissue characteristics with tissue characteristics of the abdominal muscles

  1 hour

Study Arms (3)

Healthy volunteers

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

Other: Contrast-enhanced MRI; Other: Measurement of respiratory muscle force

COVID-19 patients

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

Other: Contrast-enhanced MRI; Other: Measurement of respiratory muscle force

ICU patients

Patients discharged from the ICU after invasive ventilation for ARDS.

Other: Contrast-enhanced MRI; Other: Measurement of respiratory muscle force

Interventions

Contrast-enhanced MRI OTHER

Contrast-enhanced MRI

COVID-19 patients; Healthy volunteers; ICU patients

Measurement of respiratory muscle force OTHER

Measurement of the maximum inspiratory and expiratory pressure.

COVID-19 patients; Healthy volunteers; ICU patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

Amsterdam UMC, location VUmc

Amsterdam, North Holland, 1081HV, Netherlands

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Leo Heunks, Prof. Dr.

CONTACT

(020) 444 4444; l.heunks@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: February 3, 2021
• Study Start: February 3, 2021
• Primary Completion: January 19, 2023
• Study Completion: January 19, 2023
• Last Updated: March 18, 2021

Record last verified: 2021-03

Locations

NL (1)