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
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ching-Yu Yang
- 電話番号：+886972652407
- メール：ycyyang@ntuh.gov.tw
研究連絡先のバックアップ
- 名前：Shang-Ping Yang
- 電話番号：+886910859033
- メール：spy201211@gmail.com
研究場所
-
-
-
Taipei、台湾、100
- 募集
- National Taiwan University Hospital
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Patients undergoing cataract surgery.
Exclusion Criteria:
- Age under 18 years.
- Unable to follow verbal instructions.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Smart Bed-Exit Alert System
Participants will receive standard nursing care with the UNEO smart bed-exit alert system during the preoperative waiting period.
|
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.
|
|
介入なし：Standard Nursing Care
Participants will receive routine preoperative nursing care without the UNEO smart bed-exit alert system during the preoperative waiting period.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Frequency of nurse bedside visits
時間枠：During the preoperative waiting period before entering the operating room (approximately 30-60 minutes).
|
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
時間枠：During the preoperative waiting period before entering the operating room.
|
Total nursing care time provided during the preoperative waiting period.
|
During the preoperative waiting period before entering the operating room.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 202509153RIPB
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。