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
研究概览
地位
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Istanbul、土耳其(türkiye)、340000
- Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的: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.
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有源比较器: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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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Operation Time
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Command Acknowledgment Time
大体时间: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
大体时间: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
大体时间: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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合作者和调查者
调查人员
- 首席研究员:ONUR GULTEKIN, MD、FATIH SULTAN MEHMET RESEARCH AND TRANING HOSPITAL
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- ANC-ACL-26
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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