Assessing Muscle Metabolic Phenotype by MSK Ultrasound

Suspended

• Conditions: Ultrasound; CT; MuscleSound

• Registration Number: NCT04353648
• Lead Sponsor: Duke University

Brief Summary

The purpose of this study is to test whether ultrasound images (pictures) can be used as a valid assessment of muscle quality in different muscle groups during Intensive Care stay. This new approach would allow clinicians to obtain frequent skeletal muscle images and would enable doctors to observe any changes over time in muscle quality that could occur during ICU stay.

Participants in this study will have ultrasound images made of their leg-, chest- and jaw muscles taken on every day until ICU discharge.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-16
• Study First Posted: 2020-04-20
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-08
• Last Update Posted: 2023-12-12
• Primary Completion: 2024-07-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• admission Duke Trauma center, SICU, MICU, or CT ICU
• >18 years of age

Read More

Exclusion Criteria

• <18 years of age
• prisoners

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Muscle Quality from the rectus femoris, vastus lateralis, intermedius, intercostalis, temporalis and styloglossus	Minimum of every other day while in ICU (up to 10 days). Once discharged from ICU minimum of 3x a week until discharge (up to 3 weeks)	Ultrasound-derived area of intramuscular adipose tissue (IMAT) and intramuscular glycogen content from the rectus femoris, vastus lateralis, intermedius, intercostalis, temporalis and styloglossus
Muscle volume and thickness from the rectus femoris, vastus lateralis, intermedius, intercostalis, temporalis and styloglossus	Minimum of every other day while in ICU (up to 10 days). Once discharged from ICU minimum of 3x a week until discharge (up to 3 weeks)	Ultrasound-derived volume and thicknessfrom the rectus femoris, vastus lateralis, intermedius, intercostalis, temporalis and styloglossus

Secondary Outcome Measures

Name	Time	Method
Changes of Intramuscular adipose tissue (IMAT) content and muscle volume/thickness from the psoas at the Level of L3/L4	Up to 1 year	the change over time of (standard of care) CT-derived area of intramuscular adipose tissue in cm2
Changes of Intramuscular adipose tissue (IMAT) content and muscle volume/thickness from the intercostal muscle at the Level of the head	Up to 1 year	the change over time of (standard of care) CT-derived area of intramuscular adipose tissue in cm2
Changes of Intramuscular adipose tissue (IMAT) content and muscle volume/thickness from the intercostal muscle at the Level of Th3/Th4	Up to 1 year	the change over time of (standard of care) CT-derived area of intramuscular adipose tissue in cm2

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States