Clinical trial NCT06728722: Ultrasound Detection of Body Composition in Critical Care
Official title: Detection of the Changes in Body Composition of Critically Ill Obstetrics by Ultrasound and the Co-relations With Clinical Outcomes; a Prospective Observational Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Muscle Loss
Extracellular Fluid Alteration
Critical Illness
Pregnancy Complications
Gynecologic Disease
Keywords: ultrasound
body composition
critical illness
peripartum and gynecological cases
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 121
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill women whether pregnant, peripartum, postoperative, or admitted for any critical illness.

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.

Eligibility criteria: 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

Primary outcomes:
measure: change in body composition-muscular element
timeFrame: on the day of admission , repeated every 2 days till death or discharge which come first, assessed up to 20 days from admission
measure: change in body composition-fat element
timeFrame: on the day of admission , repeated every 2 days till death or discharge which come first, assessed up to 20 days from admission.
measure: change in body composition-extreacellular oedema element
timeFrame: on the day of admission , repeated every 2 days till death or discharge which come first .
Secondary outcomes:
measure: 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.
timeFrame: 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
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.