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

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).

Study Overview

• Status: Completed
• Conditions: Critical Illness; Muscle Atrophy

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 Type: Observational
• Enrollment (Actual): 215

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of ECMO duration	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	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	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	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	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	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	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	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	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	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	Using total muscle quantity and quality measured from CT slice of the third lumbar region.	6 months post-ICU discharge
All cause mortality	Using total muscle quantity and quality measured from CT slice of the third lumbar region.	Hospital discharge (expected to be about 28 days)

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Investigators: Principal Investigator: Danielle E Bear, MRes, Guy's and St Thomas' NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2017
• Primary Completion (Actual): May 31, 2018
• Study Completion (Actual): May 31, 2018

Study Registration Dates

• First Submitted: June 23, 2017
• First Submitted That Met QC Criteria: August 29, 2017
• First Posted (Actual): September 1, 2017

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 14, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Disease Attributes; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Atrophy; Muscular Atrophy; Critical Illness
• Other Study ID Numbers: 17/WA/0166

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No