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临床试验/NCT07693829
NCT07693829招募中不适用

A Study on the Application of Smart Bed-Exit Alert Assistive Devices for Detecting Preoperative Bed Exits in Ophthalmic Surgery Patients in the Operating Room

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2026年4月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
160
试验地点
1
主要终点
Frequency of nurse bedside visits

研究概览

简要总结

This prospective, randomized interventional study aims to evaluate the effectiveness of a smart bed-exit alert system for patients undergoing cataract surgery during the preoperative waiting period. Participants will be randomly assigned to either the smart bed-exit alert system group or the standard care group. The study will compare nurse bedside visit frequency and nursing care time during the preoperative waiting period to evaluate whether the smart bed-exit alert system improves patient safety and nursing care efficiency.

详细描述

Patients undergoing cataract surgery remain on a stretcher in the operating room holding area for approximately 30-60 minutes while awaiting adequate pupil dilation. During this period, patients may attempt to leave the bed because of physiological needs (e.g., toileting) or psychological factors (e.g., anxiety or seeking family members), increasing the risk of falls and compromising patient safety.

This prospective, randomized interventional study will enroll 160 adult cataract surgery patients. Participants will be randomly assigned in a 1:1 ratio to either the intervention group (smart bed-exit alert system) or the control group (standard nursing care).

The intervention group will be monitored using the UNEO smart bed-exit alert system, which consists of a pressure-sensing mattress capable of detecting body position and bed-exit attempts. When a predefined bed-exit threshold is reached, the system immediately notifies nursing staff through audible and tablet alerts. The control group will receive routine nursing observation according to standard clinical practice.

The study will compare patient care requests, attempted bed exits, nurse bedside visit frequency, and direct nursing care time between the two groups to evaluate whether the smart bed-exit alert system improves nursing workflow and enhances patient safety.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing cataract surgery.

排除标准

  • Age under 18 years.
  • Unable to follow verbal instructions.

结局指标

主要结局

Frequency of nurse bedside visits

时间窗: During the preoperative waiting period before entering the operating room (approximately 30-60 minutes).

Number of nurse bedside visits during the preoperative waiting period.

Nursing care time

时间窗: During the preoperative waiting period before entering the operating room.

Total nursing care time provided during the preoperative waiting period.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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