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Not Yet RecruitingNCT06634732

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
Phase
Study type
Observational
Enrollment
125 (estimated)
Sponsor
Ruijin Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2024-11-01
Primary completion
2025-08-01
Completion
2025-12-31
First posted
2024-10-10
Last updated
2024-10-10

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT06634732. Inclusion in this directory is not an endorsement.