NCT07693829

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress40%
Apr 2026Dec 2026

Study Start

First participant enrolled

April 23, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 9, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

July 9, 2026

Status Verified

July 1, 2026

Enrollment Period

8 months

First QC Date

July 3, 2026

Last Update Submit

July 3, 2026

Conditions

Keywords

Smart Bed-Exit Alert SystemPatient SafetyPressure SensorNursing EfficiencyCataract Surgery

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

EXPERIMENTAL

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

Device: Smart Bed-Exit Alert System

Standard Nursing Care

NO INTERVENTION

Participants 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.

Smart Bed-Exit Alert System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

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

Locations