Alarms, Critical Care Medicine, Mechanical Ventilation, Radiographic Image Interpretation, Computer-Assisted
Conditions
Keywords
Chest X-ray, Chest radiograph, Endotracheal tube, Intubation, Intratracheal
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.
Interventions
OTHEREndotracheal Tube Position Anomaly Alerting System
The Endotracheal Tube Position Anomaly Alerting System (ETPAAS) is designed to assist healthcare providers in managing patients receiving mechanical ventilation via an endotracheal tube. This system integrates an artificial intelligence (AI) algorithm that automatically evaluates the appropriateness of endotracheal tube positioning whenever a patient's chest X-ray is uploaded. If the system detects that the distance between the endotracheal tube tip and the carina falls outside the optimal range, it promptly alerts healthcare providers, enabling timely intervention to correct the tube position and enhance patient safety.
Sponsors
Kaohsiung Medical University Chung-Ho Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients admitted to the intensive care unit * At least 18 years old
Exclusion criteria
* Patients disagree to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of endotracheal tube malposition | from the initial detection of endotracheal tube malposition to its correction, an estimated average of 48 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Usability and user satisfaction survey with a questionnaire | through study completion, up to 6 months | — |
| 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. |
| 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. |
Countries
Taiwan
Contacts
Primary ContactMing-Ju Tsai, M.D., Ph.D.
Outcome results
None listed