Ultrasound Detection of Body Composition in Critical Care

NCT ID: NCT06728722

Last Updated: 2026-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

121 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-02-15

Study Completion Date

2026-05-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Muscle Loss Extracellular Fluid Alteration Critical Illness Pregnancy Complications Gynecologic Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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critically ill obstetrics patients , admitted to ICU

ultrasound detection of body composition

Intervention Type 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

ultrasound detection of body composition

Intervention Type 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.

Interventions

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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

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ain shams university

Cairo, Cairo Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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wessam selima, MD

Role: CONTACT

01001958858

Facility Contacts

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Anesthesia department

Role: primary

010009499962

References

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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.

Reference Type BACKGROUND
PMID: 36997242 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32742962 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36934293 (View on PubMed)

Other Identifiers

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FMASU R149/2024

Identifier Type: -

Identifier Source: org_study_id

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