Ultrasound Detection of Body Composition in Critical Care

NCT06728722 | Recruiting

• 1 other identifier: FMASU R149/2024
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Muscle Loss; Extracellular Fluid Alteration; Critical Illness; Pregnancy Complications; Gynecologic Disease

Keywords

ultrasound; body composition; critical illness; peripartum and gynecological cases

Outcome Measures

Primary Outcomes (3)

• 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 1. = Muscle fascia and bone surface visible 2. = muscle fascia and bone surface still possible to spot 3. = 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 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.

  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

Study Arms (2)

critically ill obstetrics patients , admitted to ICU

Diagnostic Test: ultrasound detection of body composition

critically ill gynecological cases, admitted to ICU

Diagnostic Test: ultrasound detection of body composition

Interventions

ultrasound detection of body composition DIAGNOSTIC_TEST

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 1. = Muscle fascia and bone surface visible 2. = muscle fascia and bone surface still possible to spot 3. = 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; critically ill obstetrics patients , admitted to ICU

Eligibility Criteria

• Age: 16 Years+
• Gender Eligibility Details: critically ill pregnant or peripartum or gynecological critical illness
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Patient refusal

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, Cairo Governorate, 11528, Egypt

RECRUITING

Related Publications (3)

• 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.

  PMID: 36997242 BACKGROUND

• 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.

  PMID: 32742962 BACKGROUND

• 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.

  PMID: 36934293 BACKGROUND

MeSH Terms

Conditions

Muscular Atrophy; Critical Illness; Pregnancy Complications; Genital Diseases, Female

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Disease Attributes; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Female Urogenital Diseases; Genital Diseases

Central Study Contacts

wessam selima, MD

CONTACT

01001958858; w.z.selima@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2024
• First Posted: December 11, 2024
• Study Start: December 15, 2024
• Primary Completion: March 25, 2026
• Study Completion (Estimated): May 28, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: it will be available after completion and acceptance from a peer reviewed journal and upon reasonable request
• Access Criteria: upon reasonable request from one of the authors.

Locations

EG (1)