NCT07001696

Brief Summary

This prospective cross-sectional study aims to develop and validate a machine learning model that combines chest X-ray findings with arterial blood gas (ABG) analysis to assess the necessity for mechanical ventilation in critically ill adult patients. Conducted at Zagazig University Hospitals, the study seeks to improve clinical decision-making by integrating radiological and biochemical data using artificial intelligence. The model's predictive performance will be evaluated against standard clinical assessments.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,160

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

June 3, 2025

Status Verified

May 1, 2025

Enrollment Period

7 months

First QC Date

May 24, 2025

Last Update Submit

May 24, 2025

Conditions

Keywords

Mechanical VentilationRespiratory FailureCritical IllnessArtificial IntelligenceChest X-RayArterial Blood Gas

Outcome Measures

Primary Outcomes (1)

  • Accuracy of Machine Learning Model in Predicting the Need for Mechanical Ventilation

    Comparison of the machine learning model's prediction with actual clinical decision regarding mechanical ventilation. Accuracy will be measured using sensitivity, specificity, area under the ROC curve (AUC), and confusion matrix.

    Within 24 hours of patient presentation

Study Arms (2)

Group 1 - Patients Requiring Mechanical Ventilation

Critically ill adult patients who are clinically assessed to require mechanical ventilation. Data collected include chest X-ray findings and ABG parameters.

Group 2 - Control Group (No Mechanical Ventilation Required)

Age- and sex-matched critically ill patients who do not require mechanical ventilation. Data collected similarly for model comparison.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will enroll adult critically ill patients presenting to the Emergency Department and Intensive Care Units (ICUs) at Zagazig University Hospitals. Eligible patients include those evaluated for potential mechanical ventilation based on clinical judgment, arterial blood gas (ABG) results, and chest X-ray findings. A matched control group of critically ill patients who do not require mechanical ventilation will also be included. The study population will be diverse in terms of age, sex, and underlying diagnoses to ensure generalizability of the machine learning model.

You may qualify if:

  • Critically ill adult patients aged 18 years or older.
  • Patients assessed to require mechanical ventilation.
  • Control group: Age- and sex-matched critically ill patients not requiring mechanical ventilation.
  • Availability of both chest X-ray and arterial blood gas (ABG) analysis at the time of evaluation.

You may not qualify if:

  • Patients with missing or incomplete data (e.g., absent chest X-ray or ABG results).
  • Patients with chronic lung diseases unrelated to the current admission (e.g., COPD, pulmonary fibrosis).
  • Pregnant females.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine, zagazig university

Zagazig, Al Sharqia, 44151, Egypt

RECRUITING

MeSH Terms

Conditions

Respiratory InsufficiencyCritical Illness

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2025

First Posted

June 3, 2025

Study Start

June 1, 2025

Primary Completion

December 31, 2025

Study Completion

January 30, 2026

Last Updated

June 3, 2025

Record last verified: 2025-05

Locations