Feasibility and Reliability of Ultrasound in Acute Burns.

Feasibility and Reliability of Ultrasound Assessment of Muscle Architecture in Acute Burns.

This trial investigates the feasibility and reliability of different ultrasound protocols to determine quadriceps muscle architecture in acutely admitted burn patients. The results of this trial will provide more clarity as to whether ultrasound can be used as a bedside tool to monitor muscle wasting.

Study Overview

• Status: Completed
• Conditions: Burns
• Intervention / Treatment: Other: Burn subjects

Detailed Description

BACKGROUND Despite the ubiquity of muscle wasting following burns, practical and accurate tools to measure the degree of muscle wasting are lacking in burn care. Ultrasound has been used for this purpose in the critically-ill population and has shown to be valid and reliable. Whether this can be extrapolated to the burn population, however, remains unclear. Open wounds, fluid status, and uncertainty regarding which protocol to use are amongst factors that complicate the use of ultrasound during the acute phase of burns.

AIM This study examines the reliability and feasibility of ultrasound measures in the acute burn setting comparing different techniques and locations of application.

METHODS Burned adults were assessed at admission in two Belgian burn centers by two trained assessors using B-mode ultrasound with a linear transducer. Ultrasound-derived variables included quadriceps muscle layer thickness (QMLT) and rectus femoris cross-sectional area (RF-CSA) on both thighs. Both maximum and minimum compression techniques were used for QMLT, while RF-CSA was determined by minimum compression only. QMLT was measured at a proximal and distal location on the thigh, and RF-CSA was measured at the most proximal location possible where the entire muscle belly still remained visible.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2060
    • Ziekenhuis Netwerk Antwerpen Stuivenberg
  • Brussels, Belgium, 1120
    • Militaire Hospitaal Koningin Astrid, Neder-Over-Heembeek

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Burn subjects will be recruited from two specialised burn services in Belgium on a consecutive sampling basis during recruitment of a larger trial investigating the effects of exercise in the acute phase of burns [NCT04511104].

Healthy subjects will be recruited by convenience sampling at the M2Run Metabolic Research Unit of the Department of Rehabilitation Sciences and Physiotherapy at the University of Antwerp.

Description

Burn subjects:

Inclusion Criteria:

• ≥10 - ≤80 %TBSA
• Burn depth: 2nd deep / 3rd degree

Exclusion Criteria:

• Electrical burn (except flash burns)
• Associated injury: fracture lower limb
• Diabetes Mellitus type 1
• Central / peripheral neurological/neuromuscular disorders (interfering with exercise)
• Cognitive / psychological disorders (interfering with cooperation)
• Cardiopulmonary disease (interfering with exercise safety)
• Pregnancy
• Palliative care

Healthy subjects:

• none

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Burn subjects; exposure to burn injury	Other: Burn subjects; see eligibility criteria
Non-burned control; no exposure to burn injury

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reliability	Interrater reliability of QMLT and RF-CSA assessed by intraclass correlation	<72 hours of admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of measurements	Feasibility of different techniques and locations of measurements, assessed by number of realised vs attempted measurements	<72 hours of admission

Collaborators and Investigators

• Sponsor: Universiteit Antwerpen
• Collaborators: Research Foundation Flanders
• Investigators: Principal Investigator: Ulrike Van Daele, PhD, University of Antwerp, Faculty of Medicine and Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2020
• Primary Completion (Actual): April 6, 2021
• Study Completion (Actual): April 6, 2021

Study Registration Dates

• First Submitted: April 15, 2021
• First Submitted That Met QC Criteria: April 15, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Actual): October 19, 2021
• Last Update Submitted That Met QC Criteria: October 11, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Ultrasound; Feasibility; Reliability; Burns; Muscle wasting; Muscular Atrophy
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: 11B8619N[US]

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Datasets will be made available upon request.

Drug and device information, study documents

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