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Not yet recruiting NCT06857019

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

No phase Interventional Critical Care Medicine Mechanical Ventilation Radiographic Image Interpretation, Computer-Assisted Alarms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: "Endotracheal Tube Position Anomaly Alerting System".
Who it may be relevant to
Registry conditions: Critical Care Medicine, Mechanical Ventilation, Radiographic Image Interpretation, Computer-Assisted, Alarms. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

  • 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 ran

Primary outcome measures

  • Duration of endotracheal tube malposition [Time frame: from the initial detection of endotracheal tube malposition to its correction, an estimated average of 48 hours]
Secondary outcome measures (10)
  • Usability and user satisfaction survey with a questionnaire [Time frame: through study completion, up to 6 months]
  • Prevalence of endotracheal tube malposition [Time frame: 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]
  • Duration of mechanical ventilation [Time frame: 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]
  • Accuracy of the ETPAAS [Time frame: through study completion, up to 6 months]
  • Precision of the ETPAAS [Time frame: through study completion, up to 6 months]
  • Recall of the ETPAAS [Time frame: through study completion, up to 6 months]
  • F1 score of the ETPAAS [Time frame: 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]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Patients disagree to participate in the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Other

Study locations

Taiwan · 1 center
  • Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City

Identifiers

NCT: NCT06857019 · KMUHIRB-F(I)-20240327

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗