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Идёт набор NCT06728722

Ultrasound Detection of Body Composition in Critical Care

Наблюдательное Muscle Loss Extracellular Fluid Alteration Critical Illness Pregnancy Complications

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: ultrasound detection of body composition.
Кому может быть актуально
Состояния в реестре: Muscle Loss, Extracellular Fluid Alteration, Critical Illness, Pregnancy Complications. Базовые параметры: от 16 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Detection of the Changes in Body Composition of Critically Ill Obstetrics by Ultrasound and the Co-relations With Clinical Outcomes; a Prospective Observational Study.

Обзор

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.

Подробное описание

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.

Вмешательства

  • Диагностический тест 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 evalu

Первичные конечные точки

  • change in body composition-muscular element [Срок оценки: 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 body composition-fat element [Срок оценки: 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 body composition-extreacellular oedema element [Срок оценки: on the day of admission , repeated every 2 days till death or discharge which come first .]
Вторичные конечные точки (1)
  • 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. [Срок оценки: 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]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • Patient refusal

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Египет · 1 центр
  • Ain shams university — Cairo

Публикации

  • 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. PMID 36997242
  • 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. PMID 32742962
  • 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. PMID 36934293

Идентификаторы

NCT: NCT06728722 · FMASU R149/2024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗