- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05276921
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 (SARCOPENIE)
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 Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Dijon, France
- CHU Dijon Bourgogne
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Patient
Postoperative ICU patient
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Quadriceps and abdominal muscle ultrasonography
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Ultrasound mesure of thickness of quadriceps and abdominal muscles
Time Frame: at inclusive
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at inclusive
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DRANSART BOUDINA 2019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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