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临床试验/NCT06857019
NCT06857019尚未招募不适用

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

Kaohsiung Medical University Chung-Ho Memorial Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年2月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
试验地点
1
主要终点
Duration of endotracheal tube malposition

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •Patients disagree to participate in the study

研究组 & 干预措施

ETPAAS

Experimental

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

干预措施: "Endotracheal Tube Position Anomaly Alerting System" (Other)

Control

No Intervention

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

结局指标

主要结局

Duration of endotracheal tube malposition

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

次要结局

  • 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)
  • Accuracy of the ETPAAS(through study completion, up to 6 months)
  • Precision of the ETPAAS(through study completion, up to 6 months)
  • Recall of the ETPAAS(through study completion, up to 6 months)
  • F1 score of the ETPAAS(through study completion, up to 6 months)
  • Area under the curve (AUC) of receiver operating characteristic (ROC) curve of the ETPAAS(through study completion, up to 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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