BurnsNCT04852133
Feasibility and Reliability of Ultrasound in Acute Burns.
An observational study of Burns, run by Universiteit Antwerpen at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burns
- What is being tested?
- Burn subjects
- How many people
- 20 participants
- Where
- 2 sitesBelgium
- Study dates
- 4 May 2020to 6 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- ≥10 - ≤80 %TBSA
- Burn depth: 2nd deep / 3rd degree
Who cannot join
- 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)
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- Pregnancy
- Palliative care
- Healthy subjects:
- none
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Ziekenhuis Netwerk Antwerpen Stuivenberg
Antwerp, 2060
Militaire Hospitaal Koningin Astrid, Neder-Over-Heembeek
Brussels, 1120
About this study
Official title: Feasibility and Reliability of Ultrasound Assessment of Muscle Architecture 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.
Read the 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.
- Conditions
- Burns
- Being tested
- Burn subjects
- Keywords
- Burns, Ultrasound, Muscle wasting, Muscular Atrophy, Reliability, Feasibility
- Medical subject headings
- Burns, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Burn subjectsOther
see eligibility criteria
| Study group | Role | What they receive |
|---|---|---|
| Burn subjects | exposure to burn injury Receives: Other: Burn subjects | |
| Non-burned control | no exposure to burn injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability
Interrater reliability of QMLT and RF-CSA assessed by intraclass correlation
Measured: <72 hours of admission
Secondary outcomes (1)
Feasibility of measurements
Feasibility of different techniques and locations of measurements, assessed by number of realised vs attempted measurements
Measured: <72 hours of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start4 May 2020
- Primary completion6 Apr 2021
- Study completion6 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders
- Responsible party
- Principal investigator, Ulrike Van Daele, Universiteit Antwerpen
- Investigators
- Ulrike Van Daele, PhD, Principal investigator, University of Antwerp, Faculty of Medicine and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852133
- Sponsor's protocol ID
- 11B8619N[US]
- Status last verified
- Oct 2021
- First submitted
- 15 Apr 2021
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Datasets will be made available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Reliability of Ultrasound Assessment of Muscle Architecture in Acute Burns.
- ClinicalTrials.gov ID
- NCT04852133
- Acronym / sponsor ID
- 11B8619N[US]
- Conditions
- Burns
- Keywords
- Burns, Ultrasound, Muscle wasting, Muscular Atrophy, Reliability, Feasibility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- Research Foundation Flanders
- Study start
- 4 May 2020 (actual)
- Primary completion
- 6 Apr 2021 (actual)
- Study completion
- 6 Apr 2021 (actual)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Burn subjects | – | Other: Burn subjectsexposure to burn injury |
| Non-burned control | – | –no exposure to burn injury |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- ≥10 - ≤80 %TBSA
- Burn depth: 2nd deep / 3rd degree
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Burn subjectssee eligibility criteria | Other | Burn subjects |
Primary outcome
Reliability
Time frame: <72 hours of admission
Interrater reliability of QMLT and RF-CSA assessed by intraclass correlation
1 secondary outcome
Feasibility of measurements
Time frame: <72 hours of admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Individual participant dataSharing planned: No. Datasets will be made available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrike Van Daele, PhD principal investigator
University of Antwerp, Faculty of Medicine and Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burns, run by Universiteit Antwerpen at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability (time frame: <72 hours of admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.