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Feasibility and Reliability of Ultrasound in Acute Burns.

NCT ID: NCT04852133

Last Updated: 2021-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-04

Study Completion Date

2021-04-06

Brief Summary

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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

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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.

Conditions

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Burns

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Burn subjects

exposure to burn injury

Burn subjects

Intervention Type OTHER

see eligibility criteria

Non-burned control

no exposure to burn injury

No interventions assigned to this group

Interventions

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Burn subjects

see eligibility criteria

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Research Foundation Flanders

OTHER

Sponsor Role collaborator

Universiteit Antwerpen

OTHER

Sponsor Role lead

Responsible Party

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Ulrike Van Daele

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ulrike Van Daele, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Antwerp, Faculty of Medicine and Health Sciences

Locations

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Ziekenhuis Netwerk Antwerpen Stuivenberg

Antwerp, , Belgium

Site Status

Militaire Hospitaal Koningin Astrid, Neder-Over-Heembeek

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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11B8619N[US]

Identifier Type: -

Identifier Source: org_study_id