Quantitative Ultrasound Assessment of Abdominal Cavity Space

October 8, 2024 updated by: Ruijin Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Quantitative CT Scoring for Pathological Accumulations in the Abdominal Cavity Space
Time Frame: up to 3 days after admission to ICU
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
Time Frame: up to 3 days after admission to ICU
score range from 0-20, higher scores indicate a worse outcome
up to 3 days after admission to ICU

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to initiate enteral nutrition
Time Frame: up to 3 days after admission to ICU
Time to initiate enteral nutrition after admission to ICU in hours
up to 3 days after admission to ICU
Intra-abdominal pressure
Time Frame: up to 3 days after admission to ICU
Intra-abdominal pressure in mmHg
up to 3 days after admission to ICU
C-reactive protein
Time Frame: up to 3 days after admission to ICU
C-reactive protein in mg/L
up to 3 days after admission to ICU
procalcitonin
Time Frame: up to 3 days after admission to ICU
procalcitonin in ng/L
up to 3 days after admission to ICU
white blood cell count
Time Frame: 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
Time Frame: up to 28 days after admission to ICU
time to achieve enteral nutrition targets in hours
up to 28 days after admission to ICU
serum albumin
Time Frame: up to 28 days after admission to ICU
serum albumin in g/L
up to 28 days after admission to ICU
prealbumin
Time Frame: up to 28 days after admission to ICU
prealbumin in mg/L
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 CRRT (Continuous Renal Replacement Therapy) treatment in hours
up to 28 days after admission to ICU
duration of mechanical ventilation
Time Frame: up to 28 days after admission to ICU
duration of mechanical ventilation in hours
up to 28 days after admission to ICU
length of ICU stay
Time Frame: up to 28 days after admission to ICU
length of ICU stay in days
up to 28 days after admission to ICU
prognosis
Time Frame: up to 28 days after admission to ICU
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
Time Frame: up to 3 days after admission to ICU
score range from 0-71, higher scores indicate a worse outcome
up to 3 days after admission to ICU
Sequential Organ Failure Assessment
Time Frame: up to 3 days after admission to ICU
score range from 0-15, higher scores indicate a worse outcome
up to 3 days after admission to ICU
Abdominal Gastrointestinal Index score
Time Frame: up to 3 days after admission to ICU
score range from 0-4, higher scores indicate a worse outcome
up to 3 days after admission to ICU
Abdominal Gastrointestinal Index Ultrasonography Score
Time Frame: up to 3 days after admission to ICU
score range from 0-10, higher scores indicate a worse outcome
up to 3 days after admission to ICU
Gastrointestinal Ultrasound Scoring score
Time Frame: up to 3 days after admission to ICU
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
Time Frame: up to 3 days after admission to ICU
score range from 0-2, higher scores indicate a worse outcome
up to 3 days after admission to ICU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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