Ultrasound Detection of Body Composition in Critical Care

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age16+
SponsorAin Shams University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patient refusal

Trial population

Critically ill women whether pregnant, peripartum, postoperative, or admitted for any critical illness.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • ultrasound detection of body composition

    Diagnostic test

    Muscle mass and fat thickness assessed at two representative sites (rectus femoris, biceps brachii) per USVALID (Arabella, 2020). Muscle quality graded via validated 4-point Heckmatt echogenicity scale (Grade 1=normal, Grade 4=severe; full criteria in Outcome Measures).Subcutaneous fat thickness(mm) measured on rectus femoris. FLUID protocol for oedema: 36-site USEG 5-point scale . Day 0, day 2, then every 2 days untill at in-stay deterioration or death or discharge.

Treatment groups

121 Participants
are divided into 2 treatment groups
Group A: critically ill obstetrics patients , admitted to ICU1 intervention
Group B: critically ill gynecological cases, admitted to ICU1 intervention

Trial outcomes

Primary outcomes

1

change in body composition-muscular element

Change in muscle thickness (mm) and change in muscle quality, assessed by ultrasound echogenicity at two representative sites: rectus femoris (lower limb) and biceps brachii (upper limb). Muscle quality is graded using the validated four-point Heckmatt scale: Grade 1 = normal echogenicity with distinct bone reflection; Grade 2 = increased echogenicity with preserved architecture and normal bone reflection; Grade 3 = further increased echogenicity with some loss of architecture and reduced bone reflection; Grade 4 = markedly increased echogenicity with total loss of architecture and absent bone reflection. A derived ordinal muscle severity category is calculated from the highest grade observed across the two sites.

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
2

change in body composition-fat element

change in thickness of subcutaneous fat measured in mm. A derived categorical adiposity classification (low, normal, or high adipose reserve) is also calculated from this measurement.

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.
3

change in body composition-extreacellular oedema element

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 final ultrasonic subcutaneous edema score (USES) is calculated by adding scores from 36 subcutaneous sites (0-144), regionally grouped: hands (0-8), arms (0-16), thoracic wall (0-32), abdominal wall (0-32), thigh (0-24), calves (0-24), feet (0-8), with regional totals averaged to a 0-4 score per region. Lower scores indicate lower oedema severity. A derived categorical oedema severity classification is also calculated from the total score.

Time frame
on the day of admission , repeated every 2 days till death or discharge which come first .

Secondary outcomes

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.

Positive or negative correlation between change in any body composition element (muscular, fat, extracellular oedema) and poor clinical outcomes, measured by frequency of occurrence of poor outcomes in patients with positive change in any element. The muscle, oedema, and adiposity classifications above are combined into a single five-category bedside phenotype (Resilient, Vulnerable, Oedematous, Metabolically Compromised, Extreme Metabolic Risk), assessed at admission and at the point of in-stay deterioration; this composite phenotype is the primary exposure examined against outcome. Poor outcome is defined as a composite of mortality, need for ventilatory support, or need for circulatory support. ICU length of stay is analyzed separately as a continuous outcome. Additional outcomes recorded include failed extubation, need for renal replacement therapy, and need for blood transfusion

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

Other outcomes

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