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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

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What is being tested

Smart Bed-Exit Alert System

Device
Who is being recruted

Eye Diseases

+ Lens Diseases

+ Cataract

Over 18 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Services Research Study

Interventional
Study Start: April 2026
See protocol details

Summary

Principal SponsorNational Taiwan University Hospital
Study ContactChing-Yu YangMore contacts
Last updated: July 9, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 23, 2026

Actual date on which the first participant was enrolled.

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.

Principal SponsorNational Taiwan University Hospital
Study ContactChing-Yu YangMore contacts
Last updated: July 9, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

160 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Services Research Study

These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesLens DiseasesCataract

Criteria

1 inclusion criteria required to participate
Patients undergoing cataract surgery

2 exclusion criteria prevent from participating
Unable to follow verbal instructions

Age under 18 years

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will receive standard nursing care with the UNEO smart bed-exit alert system during the preoperative waiting period.

Group II

No Intervention
Participants will receive routine preoperative nursing care without the UNEO smart bed-exit alert system during the preoperative waiting period.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

National Taiwan University Hospital

Taipei, TaiwanOpen National Taiwan University Hospital in Google Maps
Recruiting
One Study Center