Evaluating the Clinical Effectiveness of "Endotracheal Tube Position Anomaly Alerting System" (ETPAAS-1)

February 26, 2025 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

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

  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Contact:
        • Contact:
          • Ming-Ju Tsai, M.D., Ph.D.
        • Contact:
          • Wei-An Chang, M.D., Ph.D.
        • Contact:
          • Chih-Hung Cheng, M.D.
        • Contact:
          • Chau-Chyun Sheu, M.D., Ph.D.

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients disagree to participate in the study

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ETPAAS
Participants receive standard of care, with "Endotracheal Tube Position Anomaly Alerting System" (ETPAAS), in the intensive care unit.
Other: "Endotracheal 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.
Other Names:
  • ETPAAS
No Intervention: Control
Participants receive standard of care, without ETPAAS, in the intensive care unit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of endotracheal tube malposition
Time Frame: from the initial detection of endotracheal tube malposition to its correction, an estimated average of 48 hours
from the initial detection of endotracheal tube malposition to its correction, an estimated average of 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability and user satisfaction survey with a questionnaire
Time Frame: through study completion, up to 6 months
through study completion, up to 6 months
Prevalence of endotracheal tube malposition
Time Frame: 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
through study completion, up to 6 months
ICU length of stay
Time Frame: from ICU admission to ICU discharge, an estimated average of 7 days
from ICU admission to ICU discharge, an estimated average of 7 days
Duration of mechanical ventilation
Time Frame: from intubation to the discontinuation of mechanical ventilation, an estimated average of 5 days
from intubation to the discontinuation of mechanical ventilation, an estimated average of 5 days
Weaning rate of mechanical ventilation
Time Frame: from intubation to the successful discontinuation of mechanical ventilation, assessed up to 5 months
from intubation to the successful discontinuation of mechanical ventilation, assessed up to 5 months
Accuracy of the ETPAAS
Time Frame: 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.
through study completion, up to 6 months
Precision of the ETPAAS
Time Frame: 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).
through study completion, up to 6 months
Recall of the ETPAAS
Time Frame: 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.
through study completion, up to 6 months
F1 score of the ETPAAS
Time Frame: 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.
through study completion, up to 6 months
Area under the curve (AUC) of receiver operating characteristic (ROC) curve of the ETPAAS
Time Frame: 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.
through study completion, up to 6 months

Collaborators and Investigators

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

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

  • Study Director: Ming-Ju Tsai, M.D., Ph.D., Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung Medical University

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)

February 24, 2025

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 16, 2025

First Submitted That Met QC Criteria

February 26, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 26, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMUHIRB-F(I)-20240327

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data obtained through this study may be made available to qualified researchers with academic interests in related fields. All shared data will be coded and stripped of any protected health information. Data sharing will be contingent upon the approval of the request and the execution of all applicable agreements (e.g., a material transfer agreement) before access is granted to the requesting party.

IPD Sharing Time Frame

Data requests may be submitted beginning 12 months after the publication of the study article. The data will be accessible for up to 24 months, with extensions considered on a case-by-case basis.

IPD Sharing Access Criteria

Access to trial IPD can be requested by qualified researchers conducting independent scientific research. Data access will be granted following the review and approval of a research proposal and a Statistical Analysis Plan (SAP), as well as the execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact the Study Director.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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