Ain shams university
Cairo, Cairo Governorate, 11528, Egypt
Location status: Recruiting
NCT Number: NCT06728722
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.
Interested in participating?
Request Info16 year and older
Female
Observational
Cairo, Cairo Governorate, 11528, Egypt
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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).
Contact information is provided by the study sponsor or research team.
Ain Shams University
Other
Detection of the Changes in Body Composition of Critically Ill Obstetrics by Ultrasound and the Co-relations With Clinical Outcomes; a Prospective Observational Study.
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