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

NCT06857019 | Not Yet Recruiting

• 1 other identifier: KMUHIRB-F(I)-20240327
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Chest X-ray; Chest radiograph; Endotracheal tube; Intubation, Intratracheal

Outcome Measures

Primary Outcomes (1)

• Duration of endotracheal tube malposition

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

Secondary Outcomes (10)

• 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

• 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

Study Arms (2)

ETPAAS

EXPERIMENTAL

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"

Control

NO INTERVENTION

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

Interventions

"Endotracheal Tube Position Anomaly Alerting System" 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.

Also known as: ETPAAS

ETPAAS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients disagree to participate in the study

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

Study Officials

• Ming-Ju Tsai, M.D., Ph.D.

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

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

+88673121101; SiegfriedTsai@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2025
• First Posted: March 4, 2025
• Study Start: February 24, 2025
• Primary Completion: July 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.

Locations

TW (1)