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Quantitative Ultrasound Assessment of Abdominal Cavity Space

Study on the Application Value of Quantitative Ultrasound Assessment Plan for Abdominal Cavity Space in Critically Ill Patients

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06634732
Enrollment
125
Registered
2024-10-10
Start date
2024-11-01
Completion date
2025-12-31
Last updated
2024-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MODS, Sepsis, Shock

Brief summary

This is a prospective observational study to observe the diagnostic efficacy of a quantitative ultrasound assessment plan for pathological accumulation in the abdominal cavity space of critically ill patients, and to explore its correlation with patient clinical outcomes.

Detailed description

Intra-abdominal lesions, such as hemorrhage and inflammation/infection, often lead to pathological accumulations, posing serious challenges for critically ill patients. These lesions can rapidly induce intra-abdominal hypertension and organ damage, which may progress to hemorrhagic or septic shock, endangering patients' lives. Intra-abdominal hemorrhage, especially surgery-related hemorrhage, is difficult to detect early, and existing assessment methods like CT scans have limited applicability in critically ill patients. Intra-abdominal infections account for a high proportion of infections in critically ill patients, with concurrent sepsis or shock having high mortality rates. Despite advancements in critical care medicine, the mortality rate from intra-abdominal infections remains stubbornly high. Accurate assessment of the source and extent of infection is crucial for treatment, yet routine physical examinations have low sensitivity in critically ill patients, making imaging examinations the primary method. However, while abdominal CT is considered the gold standard, it is limited by insufficient dynamic monitoring and difficulties in patient transport. Bedside ultrasound plays a significant role in the monitoring of critically ill patients due to its portability, non-invasiveness, and real-time dynamic capabilities. It can assess sources of hemorrhage and infection, quantify the extent of lesions, and monitor hemodynamic changes. Therefore, this study aims to develop a comprehensive ultrasound assessment protocol that covers the peritoneal cavity and posterior peritoneal space. Through a prospective observational study, we aim to validate its sensitivity and specificity in diagnosing pathological accumulations such as intra-abdominal hemorrhage/infection and explore its correlation with patient clinical outcomes.

Interventions

None listed

Sponsors

Ruijin Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age > 18 years old; * Expected ICU stay ≥ 72 hours; * Meeting one of the diagnostic criteria for intra-abdominal infection: 1) Single organ infection (such as cholecystitis, appendicitis, diverticulitis, cholangitis, pancreatitis, salpingitis, etc.), which may be accompanied by or without peritonitis, even without perforation; 2) Peritonitis, classified as primary, secondary, or recurrent; 3) Intra-abdominal abscess.

Exclusion criteria

* Patients with wounds, redness, swelling, bleeding, or other conditions at the abdominal measurement points that prevent ultrasound assessment; * Patients with intra-abdominal gas accumulation that affects abdominal ultrasound imaging, making ultrasound quantitative scoring impossible; * Patients who have not undergone abdominal CT examination within 72 hours of ICU admission; * Patients who do not consent to participate in this study.

Design outcomes

Primary

MeasureTime frameDescription
Quantitative CT Scoring for Pathological Accumulations in the Abdominal Cavity Spaceup to 3 days after admission to ICUscore range from 0-20, higher scores indicate a worse outcome
Quantitative Ultrasound Scoring for Pathological Accumulations in the Abdominal Cavity Spaceup to 3 days after admission to ICUscore range from 0-20, higher scores indicate a worse outcome

Secondary

MeasureTime frameDescription
C-reactive proteinup to 3 days after admission to ICUC-reactive protein in mg/L
procalcitoninup to 3 days after admission to ICUprocalcitonin in ng/L
white blood cell countup to 3 days after admission to ICUwhite blood cell count
time to achieve enteral nutrition targetsup to 28 days after admission to ICUtime to achieve enteral nutrition targets in hours
serum albuminup to 28 days after admission to ICUserum albumin in g/L
prealbuminup to 28 days after admission to ICUprealbumin in mg/L
Duration of Continuous Renal Replacement Therapy treatmentup to 28 days after admission to ICUDuration of CRRT (Continuous Renal Replacement Therapy) treatment in hours
duration of mechanical ventilationup to 28 days after admission to ICUduration of mechanical ventilation in hours
Time to initiate enteral nutritionup to 3 days after admission to ICUTime to initiate enteral nutrition after admission to ICU in hours
prognosisup to 28 days after admission to ICUsurvival or death when transfer out of the ICU
acute physiology and chronic health evaluation II scoreup to 3 days after admission to ICUscore range from 0-71, higher scores indicate a worse outcome
Sequential Organ Failure Assessmentup to 3 days after admission to ICUscore range from 0-15, higher scores indicate a worse outcome
Abdominal Gastrointestinal Index scoreup to 3 days after admission to ICUscore range from 0-4, higher scores indicate a worse outcome
Abdominal Gastrointestinal Index Ultrasonography Scoreup to 3 days after admission to ICUscore range from 0-10, higher scores indicate a worse outcome
Gastrointestinal Ultrasound Scoring scoreup to 3 days after admission to ICUscore range from 0-10, higher scores indicate a worse outcome
semi-quantitative ultrasound score of gastric contentup to 3 days after admission to ICUscore range from 0-2, higher scores indicate a worse outcome
length of ICU stayup to 28 days after admission to ICUlength of ICU stay in days
Intra-abdominal pressureup to 3 days after admission to ICUIntra-abdominal pressure in mmHg

Countries

China

Contacts

Primary Contactweiqing Zhang, Ph.D
weiq.zh@163.com8618521525300

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026