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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sepsis; Shock; MODS

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.

• Study Type: Observational
• Enrollment (Estimated): 125

Contacts and Locations

• Study Contact: Name: Weiqing Zhang, Ph.D; Phone Number: 8618521525300; Email: weiq.zh@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients in the Department of Critical Care Medicine at Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
observational group; Subjectives will undergo abdominal ultrasound examination immediately after receiving an abdominal CT scan.after admission to the ICU.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative CT Scoring for Pathological Accumulations in the Abdominal Cavity Space	score range from 0-20, higher scores indicate a worse outcome	up to 3 days after admission to ICU
Quantitative Ultrasound Scoring for Pathological Accumulations in the Abdominal Cavity Space	score range from 0-20, higher scores indicate a worse outcome	up to 3 days after admission to ICU

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to initiate enteral nutrition	Time to initiate enteral nutrition after admission to ICU in hours	up to 3 days after admission to ICU
Intra-abdominal pressure	Intra-abdominal pressure in mmHg	up to 3 days after admission to ICU
C-reactive protein	C-reactive protein in mg/L	up to 3 days after admission to ICU
procalcitonin	procalcitonin in ng/L	up to 3 days after admission to ICU
white blood cell count	white blood cell count	up to 3 days after admission to ICU
time to achieve enteral nutrition targets	time to achieve enteral nutrition targets in hours	up to 28 days after admission to ICU
serum albumin	serum albumin in g/L	up to 28 days after admission to ICU
prealbumin	prealbumin in mg/L	up to 28 days after admission to ICU
Duration of Continuous Renal Replacement Therapy treatment	Duration of CRRT (Continuous Renal Replacement Therapy) treatment in hours	up to 28 days after admission to ICU
duration of mechanical ventilation	duration of mechanical ventilation in hours	up to 28 days after admission to ICU
length of ICU stay	length of ICU stay in days	up to 28 days after admission to ICU
prognosis	survival or death when transfer out of the ICU	up to 28 days after admission to ICU
acute physiology and chronic health evaluation II score	score range from 0-71, higher scores indicate a worse outcome	up to 3 days after admission to ICU
Sequential Organ Failure Assessment	score range from 0-15, higher scores indicate a worse outcome	up to 3 days after admission to ICU
Abdominal Gastrointestinal Index score	score range from 0-4, higher scores indicate a worse outcome	up to 3 days after admission to ICU
Abdominal Gastrointestinal Index Ultrasonography Score	score range from 0-10, higher scores indicate a worse outcome	up to 3 days after admission to ICU
Gastrointestinal Ultrasound Scoring score	score range from 0-10, higher scores indicate a worse outcome	up to 3 days after admission to ICU
semi-quantitative ultrasound score of gastric content	score range from 0-2, higher scores indicate a worse outcome	up to 3 days after admission to ICU

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: October 8, 2024
• First Posted (Actual): October 10, 2024

Study Record Updates

• Last Update Posted (Actual): October 10, 2024
• Last Update Submitted That Met QC Criteria: October 8, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ZWQ21886-2024-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No