Effects of COVID-19 Infection and Critical Illness on Diaphragm Tissue Characteristics and Moveme… (NCT04735757) | Clinical Trial Compass
UnknownNot Applicable
Effects of COVID-19 Infection and Critical Illness on Diaphragm Tissue Characteristics and Movement, Visualized With MRI
Netherlands40 participantsStarted 2021-02-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.