Clinical trial NCT06842043: AI-Assisted Chest X-Ray for Misplaced Endotracheal and Nasogastric Tubes and Pneumothorax in Emergency and Critical Care Settings
Official title: Clinical Effectiveness and Cost-Effectiveness of Real-Time Chest X-Ray Computer-Aided Detection System for Misplaced Endotracheal and Nasogastric Tubes and Pneumothorax in Emergency and Critical Care Settings
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Endotracheal Tube
Nasogastric Tube
Pneumothorax
Keywords: Computer-aided detection system
Artificial intelligence
Pneumothorax diagnosis
Endotracheal tube
Nasogastric tube
Clinical effectiveness
Cost effectiveness
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Fu Jen Catholic University Hospital
name: Min-Sheng General Hospital
name: National Taiwan University
First posted: 2025-02-24
Enrollment: 10900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each group requires 5,450 patients.
Primary purpose: DIAGNOSTIC

Brief summary: Background Advancements in artificial intelligence (AI) have driven significant breakthroughs in computer-aided detection (CAD) for chest X-ray imaging. National Taiwan University Hospital (NTUH) research team previously developed an AI-based emergency Capstone CXR system (MOST 111-2634-F-002-015-, Capstone project), which led to the creation of a chest X-ray module. This chest X-ray module has an established model supported by extensive research and is ready for direct application in clinical trials without requiring additional model training. This study will utilize three submodules of the system: detection of misplaced endotracheal tubes, detection of misplaced nasogastric tubes, and identification of pneumothorax.

Objective This study aims to apply a real-time chest X-ray CAD system in emergency and critical care settings to evaluate its clinical and economic benefits without requiring additional chest X-ray examinations or altering standard care and procedures. The study will evaluate the CAD system's impact on mortality reduction, post-intubation complications, hospital stay duration, workload, and interpretation time, alongside a cost-effectiveness comparison with standard care.

Methods This study adopts a pilot trial and cluster randomized controlled trial design, with random assignment conducted at the ward level. In the intervention group, units are granted access to AI diagnostic results, while the control group continues standard care practices. Consent will be obtained from attending physicians, residents, and advanced practice nurses in each participating ward. Once consent is secured, these healthcare providers in the intervention group will be authorized to use the CAD system. Intervention units will have access to AI-generated interpretations, whereas control units will maintain routine medical procedures without access to the AI diagnostic outputs.

Results The study was funded in September 2024. Data collection is expected to last from January 2025 to December 2027.

Conclusions This study anticipates that the real-time chest X-ray CAD system will automate the identification and detection of misplaced endotracheal and nasogastric tubes on chest X-rays, as well as assist clinicians in diagnosing pneumothorax. By reducing the workload of physicians, the system is expected to shorten the time required to detect tube misplacement and pneumothorax, decrease patient mortality and hospital stays, and ultimately lower healthcare costs.


Eligibility criteria: Inclusion Criteria for units:

* Emergency critical care or intensive care units.
* The units included the patients requiring chest X-rays due to endotracheal intubation, nasogastric tube insertion, or ventilator use with a risk of pneumothorax.

Exclusion Criteria for units:

* The unit supervisor doesn't agree to participate in the trial.
* The unit is unable to implement the AI-assisted system (e.g., no data connection or system support).

Inclusion Criteria for Patients:

● Patients who are adults and require chest X-ray due to one of the following conditions: endotracheal intubation, nasogastric intubation, or the use of a ventilator with the potential to cause pneumothorax.

Exclusion Criteria for Patients: Patients in isolation wards or pediatric

* Patients in isolation wards.
* Patients in Infant Intensive Care Unit

Primary outcomes:
measure: In-hospital Mortality
timeFrame: During the hospital stay, an average of 1 week
Secondary outcomes:
measure: Length of Hospital Stay
timeFrame: During the hospital stay, an average of 1 week
measure: Misplacement Detection Time
timeFrame: During the hospital stay, an average of 1 week
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: