Ultrasound Detection of Body Composition in Critical Care

Recruiting

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

• Registration Number: NCT06728722
• Lead Sponsor: Ain Shams University

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.

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 Timeline

• Study First Submitted: 2024-10-19
• Study First Submitted QC: 2024-12-06
• Study First Posted: 2024-12-11
• Study Start: 2024-12-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24
• Primary Completion: 2025-03-25
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 121

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in body composition-muscular element	on the day of admission , repeated every 2 days till death or discharge which come first, assessed up to 20 days from admission	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
change in body composition-fat element	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.
change in body composition-extreacellular oedema element	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 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.

Secondary Outcome Measures

Name	Time	Method
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	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).

Trial Locations

Locations (1)

Ain shams university; 🇪🇬 Cairo, Egypt