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NCT Number: NCT06728722

Ultrasound Detection of Body Composition in Critical Care

Objective assessment of the Changes in body composition of critically ill patients is very valuable. Ultrasound stands as a solution due to its portability, bedside availability, and radiation-free technology. Those criteria are crucial for critically ill obstetrics and gynecological cases.

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Key information

Conditions

Muscle Loss Atrophy Critical Illness Disease Attributes Extracellular Fluid Alteration Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gynecologic Disease Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pregnancy Complications Signs and Symptoms Urogenital Diseases

Age range

16 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Ain shams university

Cairo, Cairo Governorate, 11528, Egypt

Location status: Recruiting

Location contact

Anesthesia department

CONTACT

[email protected]

010009499962

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ultrasound detection of body composition

Diagnostic Test

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.

Primary outcomes

  1. 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

    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.

  2. 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.

    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.

  3. 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 .

    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.

Secondary outcomes

  1. 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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

wessam selima, MD

CONTACT

[email protected]

01001958858

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Detection of the Changes in Body Composition of Critically Ill Obstetrics by Ultrasound and the Co-relations With Clinical Outcomes; a Prospective Observational Study.

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 11, 2024
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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