Feasibility and Reliability of Ultrasound in Acute Burns.

Sponsor

Universiteit Antwerpen (Other)

Overall Status

Completed

CT.gov ID

NCT04852133

Collaborator

Research Foundation Flanders (Other)

Enrollment

Locations

11.1

Actual Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Burns	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 Design

Study Type:

Observational

Actual Enrollment :

20 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

May 4, 2020

Actual Primary Completion Date :

Apr 6, 2021

Actual Study Completion Date :

Apr 6, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Burn subjects

exposure to burn injury

Other: Burn subjects

see eligibility criteria

Non-burned control

no exposure to burn injury

Outcome Measures

Primary Outcome Measures

Reliability [<72 hours of admission]
Interrater reliability of QMLT and RF-CSA assessed by intraclass correlation

Secondary Outcome Measures

Feasibility of measurements [<72 hours of admission]
Feasibility of different techniques and locations of measurements, assessed by number of realised vs attempted measurements

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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