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The Use of Computed Tomography (CT) to Measure Skeletal Muscle Quantity and Quality in Patients Receiving ECMO

14. februar 2019 opdateret af: 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).

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

215

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 100 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

N/A

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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.
On ECMO (expected to be about 10 days)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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)
Using total muscle quantity and quality measured from CT slice of the third lumbar region.
Total duration of mechanical ventilation during intensive care unit stay (expected to be around 10 days)
Discharge destination
Tidsramme: After discharge from hospital (expected to be around 28 days)
Using total muscle quantity and quality measured from CT slice of the third lumbar region.
After discharge from hospital (expected to be around 28 days)
Sequential changes in the muscle quantity over time
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)
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.
Intensive Care Unit Stay (expected to be about 2 weeks)
All cause mortality
Tidsramme: 6 months post-ICU discharge
Using total muscle quantity and quality measured from CT slice of the third lumbar region.
6 months post-ICU discharge
All cause mortality
Tidsramme: Hospital discharge (expected to be about 28 days)
Using total muscle quantity and quality measured from CT slice of the third lumbar region.
Hospital discharge (expected to be about 28 days)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Efterforskere

  • Ledende efterforsker: Danielle E Bear, MRes, Guy's and St Thomas' NHS Foundation Trust

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. juni 2017

Primær færdiggørelse (Faktiske)

31. maj 2018

Studieafslutning (Faktiske)

31. maj 2018

Datoer for studieregistrering

Først indsendt

23. juni 2017

Først indsendt, der opfyldte QC-kriterier

29. august 2017

Først opslået (Faktiske)

1. september 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. februar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. februar 2019

Sidst verificeret

1. februar 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 17/WA/0166

Plan for individuelle deltagerdata (IPD)

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