Anterior Cruciate Ligament (ACL) Tear, Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Rupture
Conditions
Keywords
Anterior Cruciate Ligament Reconstruction, ACL Reconstruction, Active Noise Cancellation, Noise-Cancelling Headphones, Operating Room Noise, Operating Room Communication, Closed-Loop Communication, Surgical Workflow, Operative Efficiency, Arthroscopy
Brief summary
Operating room noise may interfere with communication, concentration, and surgical workflow. Active noise-cancelling (ANC) headphones can reduce background auditory distractions; however, their potential benefit during surgery may depend on maintaining effective communication among surgical team members. This prospective randomized controlled trial evaluates the effect of ANC headphones integrated with a closed-loop communication system on operative efficiency and intraoperative workflow during arthroscopic anterior cruciate ligament (ACL) reconstruction. Participants undergoing primary arthroscopic ACL reconstruction are randomized to either an ANC group or a control group. In the ANC group, the surgeon, first assistant, and scrub nurse use ANC headphones connected through a closed-loop communication system during surgery. The control group undergoes surgery under standard operating room conditions. The primary outcome is operative time from skin incision to skin closure. Secondary outcomes include command acknowledgment time, instrument handover time, and repeated verbal requests assessed using objective video-based workflow analysis.
Detailed description
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.
Interventions
DEVICEActive Noise-Cancelling Headphones With Closed-Loop Communication
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.
OTHERStandard Operating Room Communication
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.
Sponsors
Fatih Sultan Mehmet Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Masking description
Masking was not feasible due to the visible nature of the surgical incision during postoperative assessments. Therefore, surgeons, participants, and outcome assessors were not blinded to group allocation.
Intervention model description
Participants were randomized in a 1:1 ratio to either active noise-cancelling headphones with closed-loop communication or standard operating room conditions.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operation Time | Intraoperative, from skin incision to completion ofskin closure | Operative time is defined as the elapsed time from skin incision to completion of skin closure and is measured in minutes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Command Acknowledgment Time | Intraoperative, during predefined standardized instrument-request events | 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. |
| Instrument Handover Time | Intraoperative, during predefined standardized instrument-request events | 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. |
| Repeated Verbal Requests | Intraoperative, during the surgical procedure | 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. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORONUR GULTEKIN, MD
FATIH SULTAN MEHMET RESEARCH AND TRANING HOSPITAL
Outcome results
None listed