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
Study Overview
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ching-Yu Yang
- Phone Number: +886972652407
- Email: ycyyang@ntuh.gov.tw
Study Contact Backup
- Name: Shang-Ping Yang
- Phone Number: +886910859033
- Email: spy201211@gmail.com
Study Locations
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Taipei, Taiwan, 100
- Recruiting
- National Taiwan University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients undergoing cataract surgery.
Exclusion Criteria:
- Age under 18 years.
- Unable to follow verbal instructions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Smart Bed-Exit Alert System
Participants will receive standard nursing care with the UNEO smart bed-exit alert system during the preoperative waiting period.
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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.
|
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No Intervention: Standard Nursing Care
Participants will receive routine preoperative nursing care without the UNEO smart bed-exit alert system during the preoperative waiting period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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During the preoperative waiting period before entering the operating room (approximately 30-60 minutes).
|
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Nursing care time
Time Frame: During the preoperative waiting period before entering the operating room.
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Total nursing care time provided during the preoperative waiting period.
|
During the preoperative waiting period before entering the operating room.
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202509153RIPB
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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