Assessing Muscle Metabolic Phenotype by MSK Ultrasound

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

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.

Study Overview

• Status: Suspended
• Conditions: Ultrasound; CT; MuscleSound

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All patients admitted to a Duke Trauma center, SICU, MICO, or CT ICU

Description

Inclusion Criteria:

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

Exclusion Criteria:

• <18 years of age
• prisoners

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Duke ICU/Trauma Center Patients; Any patient admitted to the Duke Trauma Center or Duke ICU will be approached to participate in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Paul Wischmeyer, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: April 16, 2020
• First Posted (Actual): April 20, 2020

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Pro00103143

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