- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Ching-Yu Yang
- Telefonnummer: +886972652407
- E-mail: ycyyang@ntuh.gov.tw
Undersøgelse Kontakt Backup
- Navn: Shang-Ping Yang
- Telefonnummer: +886910859033
- E-mail: spy201211@gmail.com
Studiesteder
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Taipei, Taiwan, 100
- Rekruttering
- National Taiwan University Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Patients undergoing cataract surgery.
Exclusion Criteria:
- Age under 18 years.
- Unable to follow verbal instructions.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Ingen indgriben: Standard Nursing Care
Participants will receive routine preoperative nursing care without the UNEO smart bed-exit alert system during the preoperative waiting period.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Frequency of nurse bedside visits
Tidsramme: During the preoperative waiting period before entering the operating room (approximately 30-60 minutes).
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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
Tidsramme: During the preoperative waiting period before entering the operating room.
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Total nursing care time provided during the preoperative waiting period.
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During the preoperative waiting period before entering the operating room.
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 202509153RIPB
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