Sarcopenia ICU UltrasoundSARCOPENIENCT05276921
Assessment of the Prognostic Value of the Thickness of the Quadriceps and Abdominal Muscles Measured by Ultrasound for 28-day Mortality in Postoperative ICU Patients
An observational study of Sarcopenia ICU Ultrasound, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Ultrasound measurement of muscle thickness, particularly of the quadriceps, can be used to highlight a reduction in lean mass. Sarcopenia is annvoluntary loss of lean mass, and it is a frequent and major problem in the intensive care unit (ICU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenia ICU Ultrasound
- What is being tested?
- ultrasound
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 20 Dec 2019to 26 Jun 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: postoperative ICU patient
Who may be able to join
- Person who has not opposed (or non-opposition of health care proxy for patients who are comatose or under the influence of sedative drugs) after receiving information about the study
- All adult patients admitted to the postoperative intensive care unit.
Who cannot join
- Protected adult or minor
- Pregnant or breastfeeding woman
- Lower limb amputation
- Refusal to participate of the patient or health care proxy
- Patient with pre-existing neuromuscular condition, tetra or paraplegia
- Morbid obesity as defined by BMI ≥ 40
- BPCO stage ≥ 3; heart failure with LVEF < 50%; patients with symptomatic valvulopathy
Trial locations and contacts
1 site in 1 country.
About this study
Ultrasound measurement of muscle thickness, particularly of the quadriceps, can be used to highlight a reduction in lean mass. Sarcopenia is annvoluntary loss of lean mass, and it is a frequent and major problem in the intensive care unit (ICU). Sarcopenia is associated with significant morbidity and mortality, as previously demonstrated by CT scan measurements.
Nevertheless, due to its nature and cost, it does not appears reasonable to perform CT sarcopenia evaluation in all ICU patients. Described in the literature as evolving rapidly upon admission to ICU, accurate assessment of this loss of muscle mass would allow early detection of sarcopenia and adaptation of therapeutic management, particularly nutritional and rehabilitative.
There are many advantages to evaluating sarcopenia by ultrasound measurement: simple, rapid, achievable at the patient's bedside, no exposure to radiation, non-invasive, and low cost. The abdominal muscles (external oblique, internal oblique, transverse) constitute the accessory respiratory muscles. Easily accessible by ultrasound, they are a potential target for the evaluation of sarcopenia, which could be responsible for ventilatory withdrawal failures, prolonged stays in intensive care and associated complications. The combined ultrasound measurement of the quadriceps and accessory respiratory muscles in ICU patients therefore appears to be an innovative approach. Considering the ease of implementation, the validity of ultrasound (confirmed in the literature), and the safety of the technique, we wish to evaluate the link between the muscle mass at arrival in the postoperative Intensive Care Unit of the Dijon University Hospital by ultrasound measurement of the quadriceps and accessory respiratory muscles, and: mortality, duration of mechanical ventilation, length of stay and occurrence of intercurrent events.
- Conditions
- Sarcopenia ICU Ultrasound
- Being tested
- ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundOther
Quadriceps and abdominal muscle ultrasonography
| Study group | Role | What they receive |
|---|---|---|
| Patient | Postoperative ICU patient Receives: Other: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound mesure of thickness of quadriceps and abdominal muscles
Measured: at inclusive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start20 Dec 2019
- Primary completion28 May 2020
- Study completion26 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcopenia ICU UltrasoundStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276921
- Sponsor's protocol ID
- DRANSART BOUDINA 2019
- Acronym
- SARCOPENIE
- Status last verified
- Feb 2022
- First submitted
- 28 Feb 2022
- Last updated
- 14 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Prognostic Value of the Thickness of the Quadriceps and Abdominal Muscles Measured by Ultrasound for 28-day Mortality in Postoperative ICU Patients
- ClinicalTrials.gov ID
- NCT05276921
- Acronym / sponsor ID
- SARCOPENIE / DRANSART BOUDINA 2019
- Conditions
- Sarcopenia ICU Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 28 May 2020 (actual)
- Study completion
- 26 Jun 2020 (actual)
- First posted
- 14 Mar 2022 (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.
Ultrasound measurement of muscle thickness, particularly of the quadriceps, can be used to highlight a reduction in lean mass. Sarcopenia is annvoluntary loss of lean mass, and it is a frequent and major problem in the intensive care unit (ICU). Sarcopenia is associated with significant morbidity and mortality, as previously demonstrated by CT scan measurements.
Nevertheless, due to its nature and cost, it does not appears reasonable to perform CT sarcopenia evaluation in all ICU patients. Described in the literature as evolving rapidly upon admission to ICU, accurate assessment of this loss of muscle mass would allow early detection of sarcopenia and adaptation of therapeutic management, particularly nutritional and rehabilitative.
There are many advantages to evaluating sarcopenia by ultrasound measurement: simple, rapid, achievable at the patient's bedside, no exposure to radiation, non-invasive, and low cost. The abdominal muscles (external oblique, internal oblique, transverse) constitute the accessory respiratory muscles. Easily accessible by ultrasound, they are a potential target for the evaluation of sarcopenia, which could be responsible for ventilatory withdrawal failures, prolonged stays in intensive care and associated complications. The combined ultrasound measurement of the quadriceps and accessory respiratory muscles in ICU patients therefore appears to be an innovative approach. Considering the ease of implementation, the validity of ultrasound (confirmed in the literature), and the safety of the technique, we wish to evaluate the link between the muscle mass at arrival in the postoperative Intensive Care Unit of the Dijon University Hospital by ultrasound measurement of the quadriceps and accessory respiratory muscles, and: mortality, duration of mechanical ventilation, length of stay and occurrence of intercurrent events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Other: ultrasoundPostoperative ICU patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- postoperative ICU patient
Key inclusion criteria (2 listed)
- Person who has not opposed (or non-opposition of health care proxy for patients who are comatose or under the influence of sedative drugs) after receiving information about the study
- All adult patients admitted to the postoperative intensive care unit.
Key exclusion criteria (7 listed)
- Protected adult or minor
- Pregnant or breastfeeding woman
- Lower limb amputation
- Refusal to participate of the patient or health care proxy
- Patient with pre-existing neuromuscular condition, tetra or paraplegia
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 |
|---|---|---|
| ultrasoundQuadriceps and abdominal muscle ultrasonography | Other | Patient |
Primary outcome
Ultrasound mesure of thickness of quadriceps and abdominal muscles
Time frame: at inclusive
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 14 Mar 2022.
Related trials for Sarcopenia ICU Ultrasound
RecruitingObservational study
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Dysphagia, Sarcopenia
Enrolling by invitationObservational study
Prevalence of Sarcopenia in Patients Admitted to ICU and Its Progression During Hospitalization.
Sarcopenia, Critical Illness
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia ICU Ultrasound, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 7 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 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Ultrasound mesure of thickness of quadriceps and abdominal muscles (time frame: at inclusive). 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 14 Mar 2022.