Active Noise-Cancelling Headphones With Closed-Loop Communication During Arthroscopic ACL Reconstruction (ANC-ACL-2026)
Effect of Active Noise-Cancelling Headphones With Closed-Loop Communication on Operative Efficiency During Arthroscopic Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial
調査の概要
状態
詳細な説明
Operating room noise represents a potential source of distraction and may interfere with effective communication, concentration, coordination, and surgical workflow. Active noise-cancelling headphones can reduce perceived background auditory stimuli; however, conventional noise-cancelling devices may also interfere with communication when used without a dedicated communication system.
This prospective, single-center, randomized controlled trial evaluates whether active noise-cancelling headphones integrated with a closed-loop communication system improve operative efficiency and intraoperative workflow during arthroscopic anterior cruciate ligament reconstruction.
Patients undergoing primary arthroscopic ACL reconstruction for isolated ACL rupture are randomized in a 1:1 ratio to an intervention group or a control group.
In the intervention group, the surgeon, first assistant, and scrub nurse use active noise-cancelling headphones connected through a closed-loop communication system throughout the surgical procedure. This system is designed to reduce perceived background auditory distractions while maintaining continuous verbal communication among the core surgical team. The anesthesia team does not use headphones and maintains awareness of monitor alarms, ventilator alarms, and operating room announcements. When required, communication between the anesthesia and surgical teams occurs using standard verbal communication.
In the control group, arthroscopic ACL reconstruction is performed under standard operating room conditions without active noise-cancelling headphones or an additional closed-loop communication system.
All procedures are performed using a standardized single-bundle hamstring autograft ACL reconstruction technique, standardized instrumentation, fixation systems, arthroscopic equipment, and operating room setup.
The primary objective is to evaluate the effect of ANC-assisted closed-loop communication on operative time. Secondary objectives include assessment of objective communication and workflow parameters, including command acknowledgment time, instrument handover time, and repeated verbal requests.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Istanbul、トルコ（Türkiye）、340000
- Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age between 18 and 50 years
- Primary arthroscopic anterior cruciate ligament reconstruction
- Isolated ACL rupture confirmed by clinical examination and magnetic resonance imaging
- Ability to provide written informed consent
Exclusion Criteria:
- Concomitant meniscal injury
- Multiligament knee injury
- Previous ipsilateral knee surgery
- Concomitant fracture
- Concomitant cartilage restoration procedure
- Concomitant osteotomy
- Revision ACL reconstruction
- American Society of Anesthesiologists physical status greater than III
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：他の
- 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 |
|---|---|
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実験的：ANC With Closed-Loop Communication
Participants undergo arthroscopic ACL reconstruction while the surgeon, first assistant, and scrub nurse use active noise-cancelling headphones connected through a closed-loop communication system.
The system allows continuous verbal communication among the core surgical team while reducing perceived background auditory distractions.
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Active noise-cancelling headphones connected through a closed-loop communication system are used by the surgeon, first assistant, and scrub nurse throughout arthroscopic ACL reconstruction.
The system is intended to reduce perceived background auditory distractions while maintaining continuous verbal communication among the core surgical team.
|
|
アクティブコンパレータ：Standard Operating Room Communication
Participants undergo the same standardized arthroscopic anterior cruciate ligament reconstruction under routine operating room conditions.
The surgeon, first assistant, and scrub nurse communicate using standard verbal communication without active noise-cancelling headphones or a dedicated closed-loop communication system.
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The surgical team performs arthroscopic ACL reconstruction under routine operating room conditions and communicates using standard verbal communication without active noise-cancelling headphones or a dedicated closed-loop communication system.
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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 |
|---|---|---|
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Operation Time
時間枠：Intraoperative, from skin incision to completion ofskin closure
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Operative time is defined as the elapsed time from skin incision to completion of skin closure and is measured in minutes.
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Intraoperative, from skin incision to completion ofskin closure
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Command Acknowledgment Time
時間枠：Intraoperative, during predefined standardized instrument-request events
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Command acknowledgment time is defined as the interval between the surgeon's verbal request and the first verbal acknowledgment by the first assistant or scrub nurse.
Measurements are obtained from video recordings of predefined standardized intraoperative communication events.
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Intraoperative, during predefined standardized instrument-request events
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Instrument Handover Time
時間枠：Intraoperative, during predefined standardized instrument-request events
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Instrument handover time is defined as the interval between the surgeon's verbal request for an instrument and physical delivery of the requested instrument.
Measurements are obtained from video recordings of predefined standardized intraoperative instrument-request events.
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Intraoperative, during predefined standardized instrument-request events
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Repeated Verbal Requests
時間枠：Intraoperative, during the surgical procedure
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A repeated verbal request is defined as any verbal request repeated because of an absent, delayed, or inadequate response.
The number of repeated requests is determined using video recordings of predefined standardized intraoperative communication events.
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Intraoperative, during the surgical procedure
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協力者と研究者
捜査官
- 主任研究者：ONUR GULTEKIN, MD、FATIH SULTAN MEHMET RESEARCH AND TRANING HOSPITAL
出版物と役立つリンク
一般刊行物
- Oomens P, Fu VX, Kleinrensink VEE, Kleinrensink GJ, Jeekel J. The Effects of Preferred Music on Laparoscopic Surgical Performance: A Randomized Crossover Study. World J Surg. 2020 Aug;44(8):2614-2619. doi: 10.1007/s00268-020-05523-0.
- Fancourt D, Burton TM, Williamon A. The razor's edge: Australian rock music impairs men's performance when pretending to be a surgeon. Med J Aust. 2016 Dec 12;205(11):515-518. doi: 10.5694/mja16.01045.
- Wu T, Qi H, Hui K, Hu Y, Xu M, Zhou J, Duan M. Effect of noise isolation with noise-cancelling earmuffs during laparoscopic surgery on acute postoperative pain: a clinical randomised controlled trial. BMC Anesthesiol. 2025 Oct 14;25(1):498. doi: 10.1186/s12871-025-03369-4.
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
キーワード
その他の研究ID番号
- ANC-ACL-26
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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
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