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

Completed

• Conditions: Critical Illness; Muscle Atrophy

• Registration Number: NCT03269825
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2017-06-20
• Study First Submitted: 2017-06-23
• Study First Submitted QC: 2017-08-29
• Study First Posted: 2017-09-01
• Primary Completion: 2018-05-31
• Study Completion: 2018-05-31
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-14
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All cause mortality	On ECMO (expected to be about 10 days)	Using total muscle quantity and quality measured from CT slice of the third lumbar region.

Secondary Outcome Measures

Name	Time	Method
Length of ventilation	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.
Relationship between muscle loss and total nutrition received	The total duration of ECMO (expected to be around 10 days)	Using total muscle quantity measured from CT slice of the third lumbar region.
All cause mortality	Hospital discharge (expected to be about 28 days)	Using total muscle quantity and quality measured from CT slice of the third lumbar region.
Relationship between muscle loss and rehabilitation goals met	The total duration of ECMO (expected to be around 10 days)	Using total muscle quantity measured from CT slice of the third lumbar region.
Length of ECMO duration	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.
Length of ICU admission	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.
Length of hospital stay	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.
Discharge destination	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.
Sequential changes in the muscle quantity over time	The total duration of ECMO (expected to be around 10 days)	Using total muscle quantity measured from CT slice of the third lumbar region.
Sequential changes in muscle quality over time	The total duration of ECMO (expected to be around 10 days)	Using total muscle quality measured from CT slice of the third lumbar region.

Trial Locations

Locations (1)

Guy's and St Thomas' NHS Foundation Trust; 🇬🇧 London, United Kingdom