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临床试验/NCT06634732
NCT06634732尚未招募不适用

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

Ruijin Hospital1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2024年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
125
试验地点
1
主要终点
Quantitative CT Scoring for Pathological Accumulations in the Abdominal Cavity Space

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Quantitative CT Scoring for Pathological Accumulations in the Abdominal Cavity Space

时间窗: up to 3 days after admission to ICU

score range from 0-20, higher scores indicate a worse outcome

Quantitative Ultrasound Scoring for Pathological Accumulations in the Abdominal Cavity Space

时间窗: up to 3 days after admission to ICU

score range from 0-20, higher scores indicate a worse outcome

次要结局

  • Duration of Continuous Renal Replacement Therapy treatment(up to 28 days after admission to ICU)
  • duration of mechanical ventilation(up to 28 days after admission to ICU)
  • length of ICU stay(up to 28 days after admission to ICU)
  • Time to initiate enteral nutrition(up to 3 days after admission to ICU)
  • Intra-abdominal pressure(up to 3 days after admission to ICU)
  • C-reactive protein(up to 3 days after admission to ICU)
  • procalcitonin(up to 3 days after admission to ICU)
  • white blood cell count(up to 3 days after admission to ICU)
  • time to achieve enteral nutrition targets(up to 28 days after admission to ICU)
  • serum albumin(up to 28 days after admission to ICU)
  • prealbumin(up to 28 days after admission to ICU)
  • prognosis(up to 28 days after admission to ICU)
  • acute physiology and chronic health evaluation II score(up to 3 days after admission to ICU)
  • Sequential Organ Failure Assessment(up to 3 days after admission to ICU)
  • Abdominal Gastrointestinal Index score(up to 3 days after admission to ICU)
  • Abdominal Gastrointestinal Index Ultrasonography Score(up to 3 days after admission to ICU)
  • Gastrointestinal Ultrasound Scoring score(up to 3 days after admission to ICU)
  • semi-quantitative ultrasound score of gastric content(up to 3 days after admission to ICU)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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