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

14 februari 2019 uppdaterad 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).

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

215

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Storbritannien
      • London, Storbritannien, SE1 7EH
        • Guy's and St Thomas' NHS Foundation Trust

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 100 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

N/A

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Adult Critically ill patients with severe respiratory failure requiring VV-ECMO

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
All cause mortality
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Length of ECMO duration
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)

Samarbetspartners och utredare

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Sponsor

Guy's and St Thomas' NHS Foundation Trust

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

20 juni 2017

Primärt slutförande (Faktisk)

31 maj 2018

Avslutad studie (Faktisk)

31 maj 2018

Studieregistreringsdatum

Först inskickad

23 juni 2017

Först inskickad som uppfyllde QC-kriterierna

29 augusti 2017

Första postat (Faktisk)

1 september 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

15 februari 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 februari 2019

Senast verifierad

1 februari 2019

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 17/WA/0166

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