Quantitative Ultrasound Assessment of Abdominal Cavity Space
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Sepsis, MODS, Shock. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Study on the Application Value of Quantitative Ultrasound Assessment Plan for Abdominal Cavity Space in Critically Ill Patients
Overview
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.
Primary outcome measures
- Quantitative CT Scoring for Pathological Accumulations in the Abdominal Cavity Space [Time frame: up to 3 days after admission to ICU]
- Quantitative Ultrasound Scoring for Pathological Accumulations in the Abdominal Cavity Space [Time frame: up to 3 days after admission to ICU]
Secondary outcome measures (12)
- Time to initiate enteral nutrition [Time frame: up to 3 days after admission to ICU]
- Intra-abdominal pressure [Time frame: up to 3 days after admission to ICU]
- C-reactive protein [Time frame: up to 3 days after admission to ICU]
- procalcitonin [Time frame: up to 3 days after admission to ICU]
- white blood cell count [Time frame: up to 3 days after admission to ICU]
- time to achieve enteral nutrition targets [Time frame: up to 28 days after admission to ICU]
- serum albumin [Time frame: up to 28 days after admission to ICU]
- prealbumin [Time frame: up to 28 days after admission to ICU]
- Duration of Continuous Renal Replacement Therapy treatment [Time frame: up to 28 days after admission to ICU]
- duration of mechanical ventilation [Time frame: up to 28 days after admission to ICU]
- length of ICU stay [Time frame: up to 28 days after admission to ICU]
- prognosis [Time frame: up to 28 days after admission to ICU]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai
Identifiers
NCT: NCT06634732 · ZWQ21886-2024-2