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.

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.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Pregnancy Complications; Muscle Loss; Gynecologic Disease; Extracellular Fluid Alteration
• Intervention / Treatment: Diagnostic test: ultrasound detection of body composition

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: Observational
• Enrollment (Estimated): 121

Contacts and Locations

• Study Contact: Name: wessam selima, MD; Phone Number: 01001958858; Email: w.z.selima@gmail.com

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 11528
      • Recruiting
      • Ain Shams University
      • Contact: Anesthesia department; Phone Number: 010009499962; Email: anesth_office@med.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Critically ill women whether pregnant, peripartum, postoperative, or admitted for any critical illness.

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?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
critically ill obstetrics patients , admitted to ICU	Diagnostic test: ultrasound detection of body composition; Muscle mass and fat thickness The examiner will use a five-site protocol. The protocol includes the examination of quadriceps on four sides and one bicep will be used The technique is reported by USVALID (Arabella, 2020) GRADING OF QUALITY OF ULTRASOUND SCANS - Muscle quality (fat and fibrotic infiltration) grading for each scan; = Muscle fascia and bone surface visible; = muscle fascia and bone surface still possible to spot; = muscle fascia and bone surface not distinguishable; no evaluation possible The FLUID protocol for edema will be done as follows: MEASURING POINTS 36 points, GRADING OF QUALITY: 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. Day zero, day 2 then Every 2 days if extended length.
critically ill gynecological cases, admitted to ICU	Diagnostic test: ultrasound detection of body composition; Muscle mass and fat thickness The examiner will use a five-site protocol. The protocol includes the examination of quadriceps on four sides and one bicep will be used The technique is reported by USVALID (Arabella, 2020) GRADING OF QUALITY OF ULTRASOUND SCANS - Muscle quality (fat and fibrotic infiltration) grading for each scan; = Muscle fascia and bone surface visible; = muscle fascia and bone surface still possible to spot; = muscle fascia and bone surface not distinguishable; no evaluation possible The FLUID protocol for edema will be done as follows: MEASURING POINTS 36 points, GRADING OF QUALITY: 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. Day zero, day 2 then Every 2 days if extended length.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in body composition-muscular element	Decreased muscle thickness measured by mm or change in quality by visual frey-white detection by ultrasound. The grading for each scan; = Muscle fascia and bone surface visible; = muscle fascia and bone surface still possible to spot; = muscle fascia and bone surface not distinguishable; no evaluation possible	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 body composition-fat element	change in thickness of subcutaneous fat measured in mm.	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 body composition-extreacellular oedema element	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 total Degree of edema measurement is: The final ultrasonic subcutaneous edema score (USES) will be calculated by adding scores from 36 subcutaneous sites (0-144). Each regional score will be estimated by summing the site scores of the hands (0-8), arms (0-16), thoracic wall (0-32), abdominal wall (0-32), thigh (0-24), calves (0-24), and feet (0-8). The total regional score will be divided by the number of sites in each region to the average score (0-4). the lower the score = the lower level of edema.	on the day of admission , repeated every 2 days till death or discharge which come first .

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Positive co-relation or negative correlation between both. That will be measured by the frequency of occurrence of poor clinical outcomes-mortality cardiorespiratory support or prolonged length of stay- in patients with positive change in any element (muscular-fat-extracellular edema).	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

Collaborators and Investigators

• Sponsor: Ain Shams University

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): December 15, 2024
• Primary Completion (Estimated): March 25, 2026
• Study Completion (Estimated): May 28, 2026

Study Registration Dates

• First Submitted: October 19, 2024
• First Submitted That Met QC Criteria: December 6, 2024
• First Posted (Actual): December 11, 2024

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 8, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: ultrasound; body composition; critical illness; peripartum and gynecological cases
• 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)?: YES
• IPD Sharing Time Frame: it will be available after completion and acceptance from a peer reviewed journal and upon reasonable request
• IPD Sharing Access Criteria: upon reasonable request from one of the authors.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No