Diaphragm DiseaseNCT04735757
Effects of COVID-19 Infection and Critical Illness on Diaphragm Tissue Characteristics and Movement, Visualized With MRI
An observational study of Diaphragm Disease and Covid19, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diaphragm Disease, Covid19
- What is being tested?
- Contrast-enhanced MRI and Measurement of respiratory muscle force
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Feb 2021to 19 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
- Asthma These exclusion criteria are based on the guidelines for contrast agents from the European Society for Urogenital Radiology (http://www.esur.org/guidelines/).
- Additional exclusion criteria for the case group, subset non-infected patients are:
- History of COVID-19-infection (confirmed with positive test)
- Additional exclusion criteria for the control group are:
- History of mechanical ventilation > 24 hours
- History of COVID-19-infection (confirmed with positive test)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC, location VUmc
Amsterdam, North Holland, 1081HV
Myrte Wennen, MSc, (020) 444 4444, m.wennen@amsterdamumc.nl
Myrte Wennen, MSc
About this study
Official title: 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
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
- Being tested
- Contrast-enhanced MRI, Measurement of respiratory muscle force
- Keywords
- MRI, Mechanical ventilation, Diaphragm
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast-enhanced MRIOther
Contrast-enhanced MRI
Measurement of respiratory muscle forceOther
Measurement of the maximum inspiratory and expiratory pressure.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Healthy volunteers, matched by age and gender to patient groups. Receives: Other: Contrast-enhanced MRI; Other: Measurement of respiratory muscle force | |
| COVID-19 patients | Patients discharged from the ICU after invasive ventilation for COVID-19. Receives: Other: Contrast-enhanced MRI; Other: Measurement of respiratory muscle force | |
| ICU patients | Patients discharged from the ICU after invasive ventilation for ARDS. Receives: Other: Contrast-enhanced MRI; Other: Measurement of respiratory muscle force |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue characteristics of the diaphragm
Extracted from contrast enhanced imaging
Measured: 1 hour
Movement of the diaphragm
Description of the movement of the diaphragm in 4D fashion.
Measured: 1 hour
Secondary outcomes (3)
Quantitative dynamic contrast enhanced imaging of the diaphragm
Application of modelling to describe tissue characteristics of the diaphragm using contrast inflow.
Measured: 1 hour
Correlation of movement and tissue characteristics of the diaphragm with measurements of maximum inspiratory and expiratory pressure
Measured: 1 hour
Correlation of movement and tissue characteristics of the diaphragm with clinical parameters
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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start3 Feb 2021
- Primary completion19 Jan 2023 (estimated)
- Study completion19 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaphragm DiseaseStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof.dr. L.M.A. Heunks, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735757
- Sponsor's protocol ID
- NL 72271.029.19
- Status last verified
- Mar 2021
- First submitted
- 14 Jan 2021
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04735757
- Acronym / sponsor ID
- NL 72271.029.19
- Conditions
- Diaphragm Disease, Covid19
- Keywords
- MRI, Mechanical ventilation, Diaphragm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 19 Jan 2023 (estimated)
- Study completion
- 19 Jan 2023 (estimated)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Other: Contrast-enhanced MRI, Other: Measurement of respiratory muscle forceHealthy volunteers, matched by age and gender to patient groups. |
| COVID-19 patients | – | Other: Contrast-enhanced MRI, Other: Measurement of respiratory muscle forcePatients discharged from the ICU after invasive ventilation for COVID-19. |
| ICU patients | – | Other: Contrast-enhanced MRI, Other: Measurement of respiratory muscle forcePatients discharged from the ICU after invasive ventilation for ARDS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (27 listed)
- 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:
- Obesity (BMI > 30 kg/m2 at hospital admission)
- Known pregnancy
- Contraindications for MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast-enhanced MRIContrast-enhanced MRI | Other | COVID-19 patients, Healthy volunteers, ICU patients |
| Measurement of respiratory muscle forceMeasurement of the maximum inspiratory and expiratory pressure. | Other | COVID-19 patients, Healthy volunteers, ICU patients |
Primary outcome
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.
3 secondary outcomes
Quantitative dynamic contrast enhanced imaging of the diaphragm
Time frame: 1 hour
Correlation of movement and tissue characteristics of the diaphragm with measurements of maximum inspiratory and expiratory pressure
Time frame: 1 hour
Correlation of movement and tissue characteristics of the diaphragm with clinical parameters
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diaphragm Disease and Covid19, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leo Heunks, Prof. Dr. ((020) 444 4444, l.heunks@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tissue characteristics of the diaphragm (time frame: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.