Effects of COVID-19 Infection and Critical Illness on Diaphragm Tissue Characteristics and Movement, Visualized With MRI
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.
調査の概要
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Noord-Holland
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Amsterdam、Noord-Holland、オランダ、1081HV
- 募集
- Amsterdam UMC, location VUmc
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コンタクト：
- Myrte Wennen, MSc
- 電話番号：(020) 444 4444
- メール：m.wennen@amsterdamumc.nl
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副調査官：
- Myrte Wennen, MSc
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主任研究者：
- Leo Heunks, Prof. Dr.
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
- 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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Healthy volunteers
Healthy volunteers, matched by age and gender to patient groups.
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Contrast-enhanced MRI
Measurement of the maximum inspiratory and expiratory pressure.
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COVID-19 patients
Patients discharged from the ICU after invasive ventilation for COVID-19.
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Contrast-enhanced MRI
Measurement of the maximum inspiratory and expiratory pressure.
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ICU patients
Patients discharged from the ICU after invasive ventilation for ARDS.
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Contrast-enhanced MRI
Measurement of the maximum inspiratory and expiratory pressure.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Tissue characteristics of the diaphragm
時間枠：1 hour
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Extracted from contrast enhanced imaging
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1 hour
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Movement of the diaphragm
時間枠：1 hour
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Description of the movement of the diaphragm in 4D fashion.
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1 hour
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Quantitative dynamic contrast enhanced imaging of the diaphragm
時間枠：1 hour
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Application of modelling to describe tissue characteristics of the diaphragm using contrast inflow.
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1 hour
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Correlation of movement and tissue characteristics of the diaphragm with measurements of maximum inspiratory and expiratory pressure
時間枠：1 hour
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1 hour
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Correlation of movement and tissue characteristics of the diaphragm with clinical parameters
時間枠：1 hour
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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.
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1 hour
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その他の成果指標
結果測定 |
時間枠 |
|---|---|
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Correlation of diaphragm tissue characteristics with tissue characteristics of the abdominal muscles
時間枠：1 hour
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1 hour
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- NL 72271.029.19
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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