Feasibility and Reliability of Ultrasound in Acute Burns.

Completed

• Conditions: Burns
• Interventions: Other: Burn subjects

• Registration Number: NCT04852133
• Lead Sponsor: Universiteit Antwerpen

Brief 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.

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 Timeline

• Study Start: 2020-05-04
• Primary Completion: 2021-04-06
• Study Completion: 2021-04-06
• Study First Submitted: 2021-04-15
• Study First Submitted QC: 2021-04-15
• Study First Posted: 2021-04-21
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-11
• Last Update Posted: 2021-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Burn subjects	Burn subjects	exposure to burn injury

Primary Outcome Measures

Name	Time	Method
Reliability	<72 hours of admission	Interrater reliability of QMLT and RF-CSA assessed by intraclass correlation

Secondary Outcome Measures

Name	Time	Method
Feasibility of measurements	<72 hours of admission	Feasibility of different techniques and locations of measurements, assessed by number of realised vs attempted measurements

Trial Locations

Locations (2)

Militaire Hospitaal Koningin Astrid, Neder-Over-Heembeek; 🇧🇪 Brussels, Belgium

Ziekenhuis Netwerk Antwerpen Stuivenberg; 🇧🇪 Antwerp, Belgium