The Use of Computed Tomography (CT) to Measure Skeletal Muscle Quantity and Quality in Patients Receiving ECMO
2019年2月14日 更新者：Danielle Bear、Guy's and St Thomas' NHS Foundation Trust
This is a retrospective, observational study and will investigate the clinical predictive value of and change in muscle quantity and quality in critically ill patients with severe respiratory failure requiring veno-venous extracorporeal membrane oxygenation (VV-ECMO).
調査の概要
詳細な説明
The use of veno-venous extra-corporeal membrane oxygenation (VV-ECMO) for severe respiratory failure - mainly hypoxaemia - has increased over recent years. Similar to the general population in the Intensive Care Unit (ICU), these patients become deconditioned, severely weak (ICU acquired weakness- ICUAW) and require prolonged rehabilitation after disconnection from VV-ECMO. However, data regarding the magnitude of muscle wasting and recovery in this specific group is lacking.
Both poor muscle quantity and quality have been found to be a predictor or poor outcome. As all patients receiving VV-ECMO at our hospital will get an initial CT scan of their chest, abdomen and pelvis, these CT scans will be used to measure muscle quantity and quality of different muscle groups of the abdomen at admission and then using any follow-up CT scan performed within 10 days. In addition, the relationship between the loss of muscle over the course of VV-ECMO and perceived recovery of renal function at ICU discharge will be investigated.
研究の種類
観察的
入学 (実際)
215
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
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London、イギリス、SE1 7EH
- Guy's and St Thomas' NHS Foundation Trust
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～100年 (大人、高齢者)
健康ボランティアの受け入れ
なし
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
Adult Critically ill patients with severe respiratory failure requiring VV-ECMO
説明
Inclusion Criteria:
- Critically ill patients with Severe Respiratory Failure who required VV-ECMO and had one or more CT scans of their abdomen
Exclusion Criteria:
- Critically ill patients with Severe Respiratory Failure who required VV-ECMO and did not have one or more CT scans of their abdomen
- Critically ill patients with Severe Respiratory Failure who required VV-ECMO who have a poor quality CT scan not analysable by the software
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
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 |
|---|---|---|
|
All cause mortality
時間枠：On ECMO (expected to be about 10 days)
|
Using total muscle quantity and quality measured from CT slice of the third lumbar region.
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On ECMO (expected to be about 10 days)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Length of ECMO duration
時間枠：The total duration on ECMO (expected to be an average of 10 days)
|
Using total muscle quantity and quality measured from CT slice of the third lumbar region.
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The total duration on ECMO (expected to be an average of 10 days)
|
|
Length of ICU admission
時間枠：The total duration of ICU admission (expected to be around 2 weeks)
|
Using total muscle quantity and quality measured from CT slice of the third lumbar region.
|
The total duration of ICU admission (expected to be around 2 weeks)
|
|
Length of hospital stay
時間枠：The total duration of hospital admission (expected to be around 28 days)
|
Using total muscle quantity and quality measured from CT slice of the third lumbar region.
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The total duration of hospital admission (expected to be around 28 days)
|
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Length of ventilation
時間枠：Total duration of mechanical ventilation during intensive care unit stay (expected to be around 10 days)
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Using total muscle quantity and quality measured from CT slice of the third lumbar region.
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Total duration of mechanical ventilation during intensive care unit stay (expected to be around 10 days)
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Discharge destination
時間枠：After discharge from hospital (expected to be around 28 days)
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Using total muscle quantity and quality measured from CT slice of the third lumbar region.
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After discharge from hospital (expected to be around 28 days)
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Sequential changes in the muscle quantity over time
時間枠：The total duration of ECMO (expected to be around 10 days)
|
Using total muscle quantity measured from CT slice of the third lumbar region.
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The total duration of ECMO (expected to be around 10 days)
|
|
Sequential changes in muscle quality over time
時間枠：The total duration of ECMO (expected to be around 10 days)
|
Using total muscle quality measured from CT slice of the third lumbar region.
|
The total duration of ECMO (expected to be around 10 days)
|
|
Relationship between muscle loss and total nutrition received
時間枠：The total duration of ECMO (expected to be around 10 days)
|
Using total muscle quantity measured from CT slice of the third lumbar region.
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The total duration of ECMO (expected to be around 10 days)
|
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Relationship between muscle loss and rehabilitation goals met
時間枠：The total duration of ECMO (expected to be around 10 days)
|
Using total muscle quantity measured from CT slice of the third lumbar region.
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The total duration of ECMO (expected to be around 10 days)
|
|
All cause mortality
時間枠：Intensive Care Unit Stay (expected to be about 2 weeks)
|
Using total muscle quantity and quality measured from CT slice of the third lumbar region.
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Intensive Care Unit Stay (expected to be about 2 weeks)
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All cause mortality
時間枠：6 months post-ICU discharge
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Using total muscle quantity and quality measured from CT slice of the third lumbar region.
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6 months post-ICU discharge
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All cause mortality
時間枠：Hospital discharge (expected to be about 28 days)
|
Using total muscle quantity and quality measured from CT slice of the third lumbar region.
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Hospital discharge (expected to be about 28 days)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Danielle E Bear, MRes、Guy's and St Thomas' NHS Foundation Trust
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年6月20日
一次修了 (実際)
2018年5月31日
研究の完了 (実際)
2018年5月31日
試験登録日
最初に提出
2017年6月23日
QC基準を満たした最初の提出物
2017年8月29日
最初の投稿 (実際)
2017年9月1日
学習記録の更新
投稿された最後の更新 (実際)
2019年2月15日
QC基準を満たした最後の更新が送信されました
2019年2月14日
最終確認日
2019年2月1日
詳しくは
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。