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
1 other identifier
interventional
160
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 23, 2026
CompletedFirst Submitted
Initial submission to the registry
July 3, 2026
CompletedFirst Posted
Study publicly available on registry
July 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
July 9, 2026
July 1, 2026
8 months
July 3, 2026
July 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Frequency of nurse bedside visits
Number of nurse bedside visits during the preoperative waiting period.
During the preoperative waiting period before entering the operating room (approximately 30-60 minutes).
Nursing care time
Total nursing care time provided during the preoperative waiting period.
During the preoperative waiting period before entering the operating room.
Study Arms (2)
Smart Bed-Exit Alert System
EXPERIMENTALParticipants will receive standard nursing care with the UNEO smart bed-exit alert system during the preoperative waiting period.
Standard Nursing Care
NO INTERVENTIONParticipants will receive routine preoperative nursing care without the UNEO smart bed-exit alert system during the preoperative waiting period.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients undergoing cataract surgery.
You may not qualify if:
- Age under 18 years.
- Unable to follow verbal instructions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, 100, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2026
First Posted
July 9, 2026
Study Start
April 23, 2026
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
July 9, 2026
Record last verified: 2026-07