Feasibility and Reliability of Ultrasound in Acute Burns.

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04852133
• Other study ID #: 11B8619N[US]
• Status: Completed
• Start date: May 4, 2020
• Est. completion date: April 6, 2021

Study information

• Verified date: October 2021
• Source: Universiteit Antwerpen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 6, 2021
• Est. primary completion date: April 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burns

Intervention

Other:
• Burn subjects
see eligibility criteria

Locations

Country	Name	City	State
Belgium	Ziekenhuis Netwerk Antwerpen Stuivenberg	Antwerp
Belgium	Militaire Hospitaal Koningin Astrid, Neder-Over-Heembeek	Brussels

Sponsors (2)

Lead Sponsor	Collaborator
Universiteit Antwerpen	Research Foundation Flanders

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reliability	Interrater reliability of QMLT and RF-CSA assessed by intraclass correlation	<72 hours of admission
Secondary	Feasibility of measurements	Feasibility of different techniques and locations of measurements, assessed by number of realised vs attempted measurements	<72 hours of admission