An Observational Clinical Study on the Construction of an Artificial Neural Network Model for ICU Pneumonia

October 24, 2024 updated by: Chinese Medical Association

An Observational Clinical Study on the Construction of an Artificial Neural Network Model for Rapid Intelligent Diagnosis of Microorganisms in ICU Pneumonia Based on Species-specific Rapid Detection of Pathogenic Bacteria

To achieve rapid, intelligent and accurate microbiological diagnosis and treatment for ICU pneumonia, an artificial neural network model for microbiological diagnosis is established, which depends on many clinical cases and machine deep learning from clinical experts' judgements according to species-specific rapid detection of pathogenic bacteria and other clinical parameter variables of patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective single-centre observational study, 600 ICU pneumonia patients are expected to be selected as the observation object, and the lower respiratory secretions of patients on d1, d3 and d7 after enrollment are collected for species-specific rapid detection and microbial culture, while the general information of the patients and the clinical information of the corresponding time points on d1, d3 and d7 are collected. Two experienced senior physicians were organized to determine whether the microbial results were colonized or infected, and an artificial neural network model for rapid and intelligent diagnosis of pathogenic microorganisms in ICU pneumonia will be established and validated through multi-dimensional machine learning.

Study Type

Observational

Enrollment (Estimated)

600

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 Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Nanjing Drum Tower Hospital
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pneumonia patients who admitted to Nanjing Drum Tower Hospital from Jan 1,2025 to Dec 31,2027 and meet the inclusion criteria.

Description

Inclusion Criteria:

  1. aged ≥18 years;
  2. agreed to obtain lower respiratory specimens for rapid testing of pathogenic bacteria;
  3. all were enrolled by an experienced physician who dynamically determined that the microorganisms were in a colonised or infected state;
  4. signed an informed consent form.

Exclusion Criteria:

  1. pregnant women;
  2. lactating women;
  3. patients who could not obtain lower respiratory specimens;

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical evaluation of each microbial detected whether in colonization or infection
Time Frame: day1,day3 and day7 after enrollment
Two experienced senior physicians are organized to determine whether the microbial are colonized or infected according to clinical values.
day1,day3 and day7 after enrollment

Collaborators and Investigators

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

Sponsor

Chinese Medical Association

Investigators

  • Principal Investigator: Yan Wang, Master, Nanjing Drum Tower Hosptial

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)

January 1, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

September 5, 2024

First Submitted That Met QC Criteria

October 24, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

October 28, 2024

Last Update Submitted That Met QC Criteria

October 24, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-607-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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