Evaluating the Clinical Effectiveness of "Endotracheal Tube Position Anomaly Alerting System"

Not Applicable

Not yet recruiting

• Conditions: Critical Care Medicine; Mechanical Ventilation; Radiographic Image Interpretation, Computer-Assisted; Alarms

• Registration Number: NCT06857019
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary

The goal of this clinical trial is to determine whether the Endotracheal Tube Position Anomaly Alerting System (ETPAAS) effectively reduces the duration of endotracheal tube malposition in patients admitted to the intensive care unit (ICU). Additionally, the study will assess the clinical impact, usability, and user satisfaction of ETPAAS.

The main questions it aims to answer are:

* Does ETPAAS reduce the duration of endotracheal tube malposition?

* What are healthcare workers' perspectives on the usability and satisfaction of ETPAAS?

Participants will receive standard care, with or without ETPAAS, in the intensive care unit.

Researchers will evaluate the duration of endotracheal tube malposition. Healthcare workers will complete a questionnaire assessing the usability and satisfaction of ETPAAS.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-16
• Study Start: 2025-02-24
• Study First Submitted QC: 2025-02-26
• Last Update Submitted: 2025-02-26
• Study First Posted: 2025-03-04
• Last Update Posted: 2025-03-04
• Primary Completion: 2025-07-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients admitted to the intensive care unit
• At least 18 years old

Exclusion Criteria

• Patients disagree to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Duration of endotracheal tube malposition	from the initial detection of endotracheal tube malposition to its correction, an estimated average of 48 hours

Secondary Outcome Measures

Name	Time	Method
Usability and user satisfaction survey with a questionnaire	through study completion, up to 6 months
Prevalence of endotracheal tube malposition	through study completion, up to 6 months	Prevalence of endotracheal tube malposition on the first chest radiograph on ICU admission and on the second chest radiograph taken in the ICU
ICU length of stay	from ICU admission to ICU discharge, an estimated average of 7 days
Duration of mechanical ventilation	from intubation to the discontinuation of mechanical ventilation, an estimated average of 5 days
Weaning rate of mechanical ventilation	from intubation to the successful discontinuation of mechanical ventilation, assessed up to 5 months
Accuracy of the ETPAAS	through study completion, up to 6 months	The accuracy of the Endotracheal Tube Position Anomaly Alerting System (ETPAAS) will be evaluated by comparing its automated assessments of endotracheal tube (ETT) positioning with expert clinical interpretations. Accuracy will be determined based on the system's sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) in detecting ETT malposition. The reference standard will be assessments made by experienced intensivists.
Precision of the ETPAAS	through study completion, up to 6 months	The precision of the Endotracheal Tube Position Anomaly Alerting System (ETPAAS) will be evaluated by assessing the consistency and reliability of its automated endotracheal tube (ETT) position anomaly detection. Precision will be measured as the proportion of correctly identified malpositioned ETT cases among all positive alerts generated by the system (i.e., positive predictive value, PPV).
Recall of the ETPAAS	through study completion, up to 6 months	The recall of the Endotracheal Tube Position Anomaly Alerting System (ETPAAS) will be assessed by evaluating its ability to correctly identify cases of endotracheal tube (ETT) malposition. Recall will be quantified as the proportion of true positive cases detected by ETPAAS among all actual cases of ETT malposition, also known as sensitivity. A higher recall value indicates the system's effectiveness in minimizing missed detections and ensuring timely alerts for clinical intervention.
F1 score of the ETPAAS	through study completion, up to 6 months	The F1 score of the Endotracheal Tube Position Anomaly Alerting System (ETPAAS) will be used to assess the balance between precision and recall in detecting endotracheal tube (ETT) malposition. The F1 score is the harmonic mean of precision and recall. A higher F1 score indicates that ETPAAS effectively identifies ETT malposition with both high accuracy and low false-negative and false-positive rates. This metric provides a comprehensive evaluation of the system's performance in a clinical setting.
Area under the curve (AUC) of receiver operating characteristic (ROC) curve of the ETPAAS	through study completion, up to 6 months	The Area Under the Curve (AUC) of the Receiver Operating Characteristic (ROC) curve will be used to evaluate the overall diagnostic performance of the Endotracheal Tube Position Anomaly Alerting System (ETPAAS) in detecting endotracheal tube (ETT) malposition. The ROC curve plots the true positive rate (sensitivity) against the false positive rate (1 - specificity) at various classification thresholds. The AUC value ranges from 0 to 1, where: * AUC = 1.0 indicates perfect classification performance.; * AUC = 0.5 suggests no better performance than random chance.; * Higher AUC values indicate superior discriminatory ability of ETPAAS in correctly distinguishing between correctly positioned and malpositioned ETT cases.; This metric provides a robust measure of the system's reliability and effectiveness in clinical decision support.

Trial Locations

Locations (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan