NCT06728722

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.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 121 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: Female
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
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 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.

Timeline

• Start date: 2024-12-15
• Primary completion: 2026-03-25
• Completion: 2026-05-28
• First posted: 2024-12-11
• Last updated: 2026-02-11

Locations

1 site across 1 country: Egypt