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
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Istanbul, Turquía (Türkiye), 340000
- Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Operation Time
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Command Acknowledgment Time
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: ONUR GULTEKIN, MD, FATIH SULTAN MEHMET RESEARCH AND TRANING HOSPITAL
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ANC-ACL-26
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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