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

NCT ID: NCT06857019

Last Updated: 2025-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-24

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Critical Care Medicine Mechanical Ventilation Radiographic Image Interpretation, Computer-Assisted Alarms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ETPAAS

Participants receive standard of care, with "Endotracheal Tube Position Anomaly Alerting System" (ETPAAS), in the intensive care unit.

Group Type EXPERIMENTAL

"Endotracheal Tube Position Anomaly Alerting System"

Intervention Type OTHER

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.

Control

Participants receive standard of care, without ETPAAS, in the intensive care unit.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

"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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ETPAAS

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Patients disagree to participate in the study
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ming-Ju Tsai, M.D., Ph.D.

Role: STUDY_DIRECTOR

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ming-Ju Tsai, M.D., Ph.D.

Role: CONTACT

+88673121101 ext. 5901

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ming-Ju Tsai, M.D., Ph.D.

Role: primary

+88673121101 ext. 5901

Ming-Ju Tsai, M.D., Ph.D.

Role: backup

Wei-An Chang, M.D., Ph.D.

Role: backup

Chih-Hung Cheng, M.D.

Role: backup

Chau-Chyun Sheu, M.D., Ph.D.

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KMUHIRB-F(I)-20240327

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.