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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Smart Bed-Exit Alert System
  Participants assigned to the intervention group will receive standard nursing care supplemented by the smart bed-exit alert system. The pressure-sensing mattress continuously monitors patient position and generates real-time alerts when predefined bed-exit criteria are met, allowing nurses to provide timely assistance.

Первичные конечные точки

• Frequency of nurse bedside visits [Срок оценки: During the preoperative waiting period before entering the operating room (approximately 30-60 minutes).]
• Nursing care time [Срок оценки: During the preoperative waiting period before entering the operating room.]

Критерии участия

Критерии включения

• Patients undergoing cataract surgery.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Тайвань · 1 центр

• National Taiwan University Hospital — Taipei

Идентификаторы

NCT: NCT07693829 · 202509153RIPB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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