Ultrasound Detection of Body Composition in Critical Care
Detection of the Changes in Body Composition of Critically Ill Obstetrics by Ultrasound and the Co-relations With Clinical Outcomes; a Prospective Observational Study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients with acute/critical illness are particularly vulnerable to muscle loss and fluid shifts, which adversely impact clinical outcomes. Assessment of these parameters in hospital settings is often subjective and imprecise, which creates discrepancies in identification and difficulty in follow-up.
The decrease in muscle mass and/or change in the composition, and fluid overload adversely impact the clinical outcome in critically ill patients and their recovery. There is growing interest in body composition (BC) assessment techniques that can be applied in ICU settings. whole-body BC estimates, and select BC variables show promise as biomarkers of muscle health, nutrition risk, and fluid status. Studies reported that Quadriceps muscle thickness predicted increased morbidity/mortality in ICU patients and has been suggested to be an objective biomarker to determine fitness for aggressive treatment. US measures of muscle loss in the critically ill will aid in the development of appropriate intervention strategies. Alternatively, qualitative muscle evaluation through the measure of echogenicity (using image gray-scale visual analysis) is a sensitive indicator of muscle atrophy. The ultrasound can contribute to assessing necrosis, fatty infiltration, and inflammation in place of invasive muscle biopsy in critically ill patients. Ultrasound offers an important tool for early non-volitional assessment of muscle function in the critically ill.
US characterization of muscle changes would facilitate the development and monitoring of muscle-targeted nutrition and physical therapy interventions. Knowing body muscle and adipose tissue mass is essential in several clinical situations to adapt drug dose to the volume of distribution and to guide nutrition as well as physical therapy. US imaging is a practical method for the prospective assessment of SM (skeletal muscle) changes in response to illness and treatment. Previous ICU studies have focused on measurements of muscle quantity (muscle thickness and CSA) in both the quadriceps, a muscle region known to be rapidly impacted by sarcopenia, and to correlate with ICU survival. Ultrasound has been used primarily as a tool for body composition measurement in clinical nutrition. Although many recent reports have demonstrated that ultrasound could be a useful tool for nutritional assessment and body composition assessment, it is not well incorporated into ICU practice regarding nutritional assessment and follow-up This trial is the first to investigate the role of ultrasound in detecting body composition in critically ill obstetrics and gynecological cases and its correlation with clinical outcomes.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: wessam selima, MD
- Phone Number: 01001958858
- Email: w.z.selima@gmail.com
Study Locations
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Cairo Governorate
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Cairo, Cairo Governorate, Egypt, 11528
- Recruiting
- Ain Shams University
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Contact:
- Anesthesia department
- Phone Number: 010009499962
- Email: anesth_office@med.asu.edu.eg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- females with age 16 with no upper limit
- American Society of Anesthesiologists (ASA) class I, II or III,
- admitted to the obstetrics and Gynecology critical care unit
Exclusion Criteria:
- Patient refusal
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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critically ill obstetrics patients , admitted to ICU
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Muscle mass and fat thickness assessed at two representative sites (rectus femoris, biceps brachii) per USVALID (Arabella, 2020).
Muscle quality graded via validated 4-point Heckmatt echogenicity scale (Grade 1=normal, Grade 4=severe; full criteria in Outcome Measures).Subcutaneous fat thickness(mm) measured on rectus femoris.
FLUID protocol for oedema: 36-site USEG 5-point scale .
Day 0, day 2, then every 2 days untill at in-stay deterioration or death or discharge.
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critically ill gynecological cases, admitted to ICU
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Muscle mass and fat thickness assessed at two representative sites (rectus femoris, biceps brachii) per USVALID (Arabella, 2020).
Muscle quality graded via validated 4-point Heckmatt echogenicity scale (Grade 1=normal, Grade 4=severe; full criteria in Outcome Measures).Subcutaneous fat thickness(mm) measured on rectus femoris.
FLUID protocol for oedema: 36-site USEG 5-point scale .
Day 0, day 2, then every 2 days untill at in-stay deterioration or death or discharge.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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change in body composition-muscular element
Time Frame: on the day of admission , repeated every 2 days till death or discharge which come first, assessed up to 20 days from admission
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Change in muscle thickness (mm) and change in muscle quality, assessed by ultrasound echogenicity at two representative sites: rectus femoris (lower limb) and biceps brachii (upper limb).
Muscle quality is graded using the validated four-point Heckmatt scale: Grade 1 = normal echogenicity with distinct bone reflection; Grade 2 = increased echogenicity with preserved architecture and normal bone reflection; Grade 3 = further increased echogenicity with some loss of architecture and reduced bone reflection; Grade 4 = markedly increased echogenicity with total loss of architecture and absent bone reflection.
A derived ordinal muscle severity category is calculated from the highest grade observed across the two sites.
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on the day of admission , repeated every 2 days till death or discharge which come first, assessed up to 20 days from admission
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change in body composition-fat element
Time Frame: on the day of admission , repeated every 2 days till death or discharge which come first, assessed up to 20 days from admission.
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change in thickness of subcutaneous fat measured in mm.
A derived categorical adiposity classification (low, normal, or high adipose reserve) is also calculated from this measurement.
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on the day of admission , repeated every 2 days till death or discharge which come first, assessed up to 20 days from admission.
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change in body composition-extreacellular oedema element
Time Frame: on the day of admission , repeated every 2 days till death or discharge which come first .
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The examiner will use a 5-point scale of ultrasonic subcutaneous edema grade (USEG) to evaluate subcutaneous edema at each site based on echo intensity, tissue transparency, and fluid properties.
The final ultrasonic subcutaneous edema score (USES) is calculated by adding scores from 36 subcutaneous sites (0-144), regionally grouped: hands (0-8), arms (0-16), thoracic wall (0-32), abdominal wall (0-32), thigh (0-24), calves (0-24), feet (0-8), with regional totals averaged to a 0-4 score per region.
Lower scores indicate lower oedema severity.
A derived categorical oedema severity classification is also calculated from the total score.
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on the day of admission , repeated every 2 days till death or discharge which come first .
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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co-relation of the change of any elements of body composition with poor outcomes suchs such as death, need for ventilatory or circulatory support or increase the length of stay in icu.
Time Frame: from occurence of change in body composition till the poor outcome. till discharge from icu or death which come first, assessed till 20 days from admission
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Positive or negative correlation between change in any body composition element (muscular, fat, extracellular oedema) and poor clinical outcomes, measured by frequency of occurrence of poor outcomes in patients with positive change in any element.
The muscle, oedema, and adiposity classifications above are combined into a single five-category bedside phenotype (Resilient, Vulnerable, Oedematous, Metabolically Compromised, Extreme Metabolic Risk), assessed at admission and at the point of in-stay deterioration; this composite phenotype is the primary exposure examined against outcome.
Poor outcome is defined as a composite of mortality, need for ventilatory support, or need for circulatory support.
ICU length of stay is analyzed separately as a continuous outcome.
Additional outcomes recorded include failed extubation, need for renal replacement therapy, and need for blood transfusion
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from occurence of change in body composition till the poor outcome. till discharge from icu or death which come first, assessed till 20 days from admission
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Gursoy C, Alkan A, Kaya Cubuk E, Karci E, Yilmaz HO, Cakir T. Rectus abdominis and rectus femoris muscle thickness in determining nutritional risk in critically ill patients: a prospective cohort study in Turkey. BMJ Open. 2023 Mar 30;13(3):e071796. doi: 10.1136/bmjopen-2023-071796.
- Ponti F, De Cinque A, Fazio N, Napoli A, Guglielmi G, Bazzocchi A. Ultrasound imaging, a stethoscope for body composition assessment. Quant Imaging Med Surg. 2020 Aug;10(8):1699-1722. doi: 10.21037/qims-19-1048.
- Zhang W, Gu Y, Zhao Y, Lian J, Zeng Q, Wang X, Wu J, Gu Q; Chinese Critical Care Ultrasound Study Group (CCUSG). Focused liquid ultrasonography in dropsy protocol for quantitative assessment of subcutaneous edema. Crit Care. 2023 Mar 18;27(1):114. doi: 10.1186/s13054-023-04403-y.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- Urogenital Diseases
- Genital Diseases
- Neurologic Manifestations
- Nervous System Diseases
- Neuromuscular Manifestations
- Pathologic Processes
- Pathological Conditions, Anatomical
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Disease Attributes
- Atrophy
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Critical Illness
- Pregnancy Complications
- Muscular Atrophy
- Genital Diseases, Female
Other Study ID Numbers
- FMASU R149/2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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