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Active Noise-Cancelling Headphones With Closed-Loop Communication During Arthroscopic ACL Reconstruction (ANC-ACL-2026)

6. september 2026 oppdatert av: Muhammet Sivritaş, Fatih Sultan Mehmet Training and Research Hospital

Effect of Active Noise-Cancelling Headphones With Closed-Loop Communication on Operative Efficiency During Arthroscopic Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial

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.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

54

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Tyrkia (Türkiye)
      • Istanbul, Tyrkia (Türkiye), 340000
        • Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: Active 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.
Aktiv komparator: 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.
Annen: Standard 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Operation Time
Tidsramme: 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.
Intraoperative, from skin incision to completion ofskin closure

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Command Acknowledgment Time
Tidsramme: 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.
Intraoperative, during predefined standardized instrument-request events
Instrument Handover Time
Tidsramme: 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.
Intraoperative, during predefined standardized instrument-request events
Repeated Verbal Requests
Tidsramme: 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.
Intraoperative, during the surgical procedure

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Fatih Sultan Mehmet Training and Research Hospital

Etterforskere

  • Hovedetterforsker: ONUR GULTEKIN, MD, FATIH SULTAN MEHMET RESEARCH AND TRANING HOSPITAL

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

25. april 2026

Primær fullføring (Antatt)

5. oktober 2026

Studiet fullført (Antatt)

15. desember 2026

Datoer for studieregistrering

Først innsendt

11. mai 2026

Først innsendt som oppfylte QC-kriteriene

11. mai 2026

Først lagt ut (Faktiske)

15. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ANC-ACL-26

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data are not planned to be publicly shared.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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