- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Detaljert 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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Ching-Yu Yang
- Telefonnummer: +886972652407
- E-post: ycyyang@ntuh.gov.tw
Studer Kontakt Backup
- Navn: Shang-Ping Yang
- Telefonnummer: +886910859033
- E-post: spy201211@gmail.com
Studiesteder
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Taipei, Taiwan, 100
- Rekruttering
- National Taiwan University Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Patients undergoing cataract surgery.
Exclusion Criteria:
- Age under 18 years.
- Unable to follow verbal instructions.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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 inngripen: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 202509153RIPB
Legemiddel- og utstyrsinformasjon, studiedokumenter
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