Feasibility and Reliability of Ultrasound in Acute Burns.

NCT04852133 | Completed

• 1 other identifier: 11B8619N[US]
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Burns

Keywords

Burns; Ultrasound; Muscle wasting; Muscular Atrophy; Reliability; Feasibility

Outcome Measures

Primary Outcomes (1)

• Reliability

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

  <72 hours of admission

Secondary Outcomes (1)

• Feasibility of measurements

  <72 hours of admission

Study Arms (2)

Burn subjects

exposure to burn injury

Other: Burn subjects

Non-burned control

no exposure to burn injury

Interventions

Burn subjects OTHER

see eligibility criteria

Burn subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Burn subjects will be recruited from two specialised burn services in Belgium on a consecutive sampling basis during recruitment of a larger trial investigating the effects of exercise in the acute phase of burns \[NCT04511104\]. Healthy subjects will be recruited by convenience sampling at the M2Run Metabolic Research Unit of the Department of Rehabilitation Sciences and Physiotherapy at the University of Antwerp.

You may qualify if:

• ≥10 - ≤80 %TBSA
• Burn depth: 2nd deep / 3rd degree

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiteit Antwerpen: lead
• Research Foundation Flanders: collaborator

Study Sites (2)

Ziekenhuis Netwerk Antwerpen Stuivenberg

Antwerp, 2060, Belgium

Location

Militaire Hospitaal Koningin Astrid, Neder-Over-Heembeek

Brussels, 1120, Belgium

Location

MeSH Terms

Conditions

Burns; Muscular Atrophy

Condition Hierarchy (Ancestors)

Wounds and Injuries; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Ulrike Van Daele, PhD

  University of Antwerp, Faculty of Medicine and Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: April 15, 2021
• First Posted: April 21, 2021
• Study Start: May 4, 2020
• Primary Completion: April 6, 2021
• Study Completion: April 6, 2021
• Last Updated: October 19, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)