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Completed

NCT Number: NCT04852133

Feasibility and Reliability of Ultrasound 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ziekenhuis Netwerk Antwerpen Stuivenberg, Antwerp, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Burn subjects

Other

see eligibility criteria

Primary outcomes

  1. Reliability

    Time frame: <72 hours of admission

    Interrater reliability of QMLT and RF-CSA assessed by intraclass correlation

Secondary outcomes

  1. Feasibility of measurements

    Time frame: <72 hours of admission

    Feasibility of different techniques and locations of measurements, assessed by number of realised vs attempted measurements

Sponsors and collaborators

Lead sponsor

Universiteit Antwerpen

Other

Collaborators

  • Research Foundation Flanders

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 21, 2021
Registry last updated
Oct 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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