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Clinical Trials/NCT04852133
NCT04852133
Completed
Not Applicable

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

Universiteit Antwerpen2 sites in 1 country20 target enrollmentMay 4, 2020
ConditionsBurns

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Burns
Sponsor
Universiteit Antwerpen
Enrollment
20
Locations
2
Primary Endpoint
Reliability
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 4, 2020
End Date
April 6, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ulrike Van Daele

Full Professor

Universiteit Antwerpen

Eligibility Criteria

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:

Outcomes

Primary Outcomes

Reliability

Time Frame: <72 hours of admission

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

Secondary Outcomes

  • Feasibility of measurements(<72 hours of admission)

Study Sites (2)

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