The Use of Computed Tomography (CT) to Measure Skeletal Muscle Quantity and Quality in Patients Receiving ECMO
14. februar 2019 oppdatert av: 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).
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
215
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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London, Storbritannia, SE1 7EH
- Guy's and St Thomas' NHS Foundation Trust
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 100 år (Voksen, Eldre voksen)
Tar imot friske frivillige
N/A
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Adult Critically ill patients with severe respiratory failure requiring VV-ECMO
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
All cause mortality
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Length of ECMO duration
Tidsramme: 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.
|
The total duration on ECMO (expected to be an average of 10 days)
|
|
Length of ICU admission
Tidsramme: 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
Tidsramme: 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.
|
The total duration of hospital admission (expected to be around 28 days)
|
|
Length of ventilation
Tidsramme: 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
Tidsramme: 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
Tidsramme: The total duration of ECMO (expected to be around 10 days)
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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
Tidsramme: 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
Tidsramme: The total duration of ECMO (expected to be around 10 days)
|
Using total muscle quantity 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 rehabilitation goals met
Tidsramme: The total duration of ECMO (expected to be around 10 days)
|
Using total muscle quantity measured from CT slice of the third lumbar region.
|
The total duration of ECMO (expected to be around 10 days)
|
|
All cause mortality
Tidsramme: 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)
|
|
All cause mortality
Tidsramme: 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
Tidsramme: Hospital discharge (expected to be about 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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Hospital discharge (expected to be about 28 days)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Danielle E Bear, MRes, Guy's and St Thomas' NHS Foundation Trust
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
20. juni 2017
Primær fullføring (Faktiske)
31. mai 2018
Studiet fullført (Faktiske)
31. mai 2018
Datoer for studieregistrering
Først innsendt
23. juni 2017
Først innsendt som oppfylte QC-kriteriene
29. august 2017
Først lagt ut (Faktiske)
1. september 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
15. februar 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. februar 2019
Sist bekreftet
1. februar 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 17/WA/0166
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