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NCT Number: NCT07693829

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing cataract surgery.

Exclusion criteria

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

Treatment and study plan

Smart Bed-Exit Alert System

Device

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.

Primary outcomes

  1. Frequency of nurse bedside visits

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

    Number of nurse bedside visits during the preoperative waiting period.

  2. Nursing care time

    Time frame: During the preoperative waiting period before entering the operating room.

    Total nursing care time provided during the preoperative waiting period.

Study contacts

Contact information is provided by the study sponsor or research team.

Ching-Yu Yang

CONTACT

[email protected]

+886972652407

Shang-Ping Yang

CONTACT

[email protected]

+886910859033

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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