Clinical trial NCT06857019: Evaluating the Clinical Effectiveness of "Endotracheal Tube Position Anomaly Alerting System"
Official title: Evaluating the Clinical Effectiveness of "Endotracheal Tube Position Anomaly Alerting System"
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Critical Care Medicine
Mechanical Ventilation
Radiographic Image Interpretation, Computer-Assisted
Alarms
Keywords: Chest X-ray
Chest radiograph
Endotracheal tube
Intubation, Intratracheal
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Duration of endotracheal tube malposition
timeFrame: from the initial detection of endotracheal tube malposition to its correction, an estimated average of 48 hours
Secondary outcomes:
measure: Usability and user satisfaction survey with a questionnaire
timeFrame: through study completion, up to 6 months
measure: Prevalence of endotracheal tube malposition
timeFrame: through study completion, up to 6 months
measure: ICU length of stay
timeFrame: from ICU admission to ICU discharge, an estimated average of 7 days
measure: Duration of mechanical ventilation
timeFrame: from intubation to the discontinuation of mechanical ventilation, an estimated average of 5 days
measure: Weaning rate of mechanical ventilation
timeFrame: from intubation to the successful discontinuation of mechanical ventilation, assessed up to 5 months
measure: Accuracy of the ETPAAS
timeFrame: through study completion, up to 6 months
measure: Precision of the ETPAAS
timeFrame: through study completion, up to 6 months
measure: Recall of the ETPAAS
timeFrame: through study completion, up to 6 months
measure: F1 score of the ETPAAS
timeFrame: through study completion, up to 6 months
measure: Area under the curve (AUC) of receiver operating characteristic (ROC) curve of the ETPAAS
timeFrame: through study completion, up to 6 months
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
affiliation: Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung Medical University
name: Ming-Ju Tsai, M.D., Ph.D.
role: STUDY_DIRECTOR
References: