Assessing Muscle Metabolic Phenotype by MSK Ultrasound

Ultrasound Clinical Trial

Official title:

Assessment of Muscle Metabolic Phenotype by the Use of Point-of-care MSK Ultrasound Imaging.

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04353648
• Other study ID #: Pro00103143
• Status: Suspended
• Start date: November 1, 2019
• Est. completion date: December 1, 2024

Study information

• Verified date: December 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 200
• Est. completion date: December 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• admission Duke Trauma center, SICU, MICU, or CT ICU

• >18 years of age

Exclusion Criteria:

• <18 years of age

• prisoners

Related Conditions & MeSH terms

• CT
• Ultrasound

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle Quality from the rectus femoris, vastus lateralis, intermedius, intercostalis, temporalis and styloglossus	Ultrasound-derived area of intramuscular adipose tissue (IMAT) and intramuscular glycogen content 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)
Primary	Muscle volume and thickness from the rectus femoris, vastus lateralis, intermedius, intercostalis, temporalis and styloglossus	Ultrasound-derived volume and thicknessfrom 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)
Secondary	Changes of Intramuscular adipose tissue (IMAT) content and muscle volume/thickness from the psoas at the Level of L3/L4	the change over time of (standard of care) CT-derived area of intramuscular adipose tissue in cm2	Up to 1 year
Secondary	Changes of Intramuscular adipose tissue (IMAT) content and muscle volume/thickness from the intercostal muscle at the Level of Th3/Th4	the change over time of (standard of care) CT-derived area of intramuscular adipose tissue in cm2	Up to 1 year
Secondary	Changes of Intramuscular adipose tissue (IMAT) content and muscle volume/thickness from the intercostal muscle at the Level of the head	the change over time of (standard of care) CT-derived area of intramuscular adipose tissue in cm2	Up to 1 year