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Novel Integrated Tube-Bougie Prototype for Endotracheal Intubation in Airway Simulation (ITBP)

31. august 2026 oppdatert av: Huseyin Cahit Halhalli, MD

A Prospective Randomized Crossover Simulation Study Comparing an Integrated Tube-Bougie Prototype With Standard Stilet-Assisted and Gum Elastic Bougie Assisted Endotracheal Intubation

Endotracheal intubation is a critical airway management procedure that frequently requires adjunctive devices, such as stylets or elastic bougies, to facilitate successful tube placement. Although videolaryngoscopy has become increasingly common, access to videolaryngoscopes remains limited in certain clinical settings, particularly in prehospital and resource-constrained environments. Consequently, stylets and bougies continue to play an essential role in airway management. To address this need, we developed a novel integrated tube-bougie prototype that combines the guidance function of an elastic bougie with an endotracheal tube into a single device.

This prospective, randomized, crossover simulation study is designed to compare the performance of the integrated tube-bougie prototype with conventional stylet-assisted and elastic bougie-assisted endotracheal intubation. Emergency medicine residents will perform intubations using all three techniques in both normal and difficult airway simulation scenarios according to a randomized crossover sequence.

The primary outcome is the time to successful endotracheal intubation. Secondary outcomes include first-attempt intubation success, perceived procedural difficulty assessed using a visual analog scale (VAS), incidence of esophageal intubation, dental trauma, and evaluation of the learning curve using cumulative sum (CUSUM) analysis.

The findings could contribute to the development of alternative airway assistive equipment for emergency airway management and training.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Endotracheal intubation is one of the most commonly performed advanced airway procedures in emergency and critical care. Successful intubation depends not only on adequate visualization of the glottis but also on successful advancement of the endotracheal tube through the vocal cords. Adjunctive devices, such as stylets and elastic bougies, are widely used to facilitate tube placement. However, these devices require additional procedural steps and device exchanges, which may increase procedural complexity and prolong intubation time.

EPATS (Integrated Tube-Bougie Prototype) is a novel airway device developed to integrate the guidance function of an elastic bougie directly into an endotracheal tube. By combining both functions into a single device, EPATS is intended to simplify the intubation process while preserving the advantages of bougie-assisted intubation.

This prospective, randomized, crossover simulation study will evaluate the performance of EPATS compared with conventional elastic bougie-assisted and stylet-assisted endotracheal intubation. Emergency medicine residents will perform endotracheal intubation using all three techniques in both normal and difficult airway simulation scenarios according to a randomized crossover sequence. Before study initiation, all participants will receive standardized training in the use of EPATS and the elastic bougie appropriate to their level of experience. All intubation procedures will be performed under standardized simulation conditions.

The primary outcome is the time to successful endotracheal intubation. Secondary outcomes include first-attempt intubation success, perceived procedural difficulty assessed using a visual analog scale (VAS), incidence of esophageal intubation, dental trauma, and evaluation of the learning curve using cumulative sum (CUSUM) analysis.

This study will determine whether EPATS improves procedural efficiency and intubation performance compared with conventional intubation adjuncts in a standardized simulation environment.

Studietype

Intervensjonell

Registrering (Antatt)

40

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiekontakt

Studiesteder

  • Tyrkia (Türkiye)
    • Kocaeli
      • Köseköy, Kocaeli, Tyrkia (Türkiye), 41060
        • University of Health Sciences, Kocaeli City Hospital
        • Ta kontakt med:

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
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Professional Status: Being an Emergency Medicine Resident actively undergoing specialty training at the University of Health Sciences, Kocaeli City Hospital, Department of Emergency Medicine.
  • Voluntary Participation: Voluntarily agreeing to participate in the study and providing written informed consent prior to enrollment.
  • Postgraduate year (PGY) 1-4 residents.
  • Willing and able to provide written informed consent.

Exclusion Criteria:

  • Refusal to Participate: Declining to participate or refusing to provide written informed consent.
  • Physical or Neurological Limitations: Having any pre-existing physical, motor, or neurological impairment that could interfere with manual dexterity, procedural performance, or airway management simulation (e.g., hand injuries, tremors, etc.).
  • Inability to complete all study procedures.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: EPATS
Participants will perform endotracheal intubation using the EPATS (Integrated Tube-Bougie Prototype) in both normal and difficult airway simulation scenarios.
Enhet: EPATS (Integrated Tube-Bougie Prototype)
The novel integrated tube-bougie prototype developed for endotracheal intubation.
Aktiv komparator: Standard Gum Elastic Bougie
Participants will perform endotracheal intubation using a standard gum elastic bougie in both normal and difficult airway simulation scenarios.
Enhet: Standard gum elastic bougie
Standard gum elastic bougie used as an intubation adjunct.
Aktiv komparator: Standard Stylet
Participants will perform endotracheal intubation using a standard stylet in both normal and difficult airway simulation scenarios.
Enhet: Standard stylet
Standard intubating stylet used as an intubation adjunct.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to successful endotracheal intubation
Tidsramme: During the study procedure
The insertion and removal time (seconds) of the laryngoscope from the mouth will be recorded.
During the study procedure

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
First Pass Success (FPS)
Tidsramme: During the study procedure
Successful endotracheal intubation without removing the laryngoscope from the mouth. Attempts exceeding 60 seconds will be considered unsuccessful.
During the study procedure
Difficulty Assessment (VAS)
Tidsramme: At the end of the study procedure
The practitioner's difficulty perception will be measured using a 0-100 mm visual analog scale.
At the end of the study procedure
Complications (Dental trauma and Esophageal intubation)
Tidsramme: During the study procedure
Complications for each procedure (dental trauma and esophageal intubation) will be determined by the researchers.
During the study procedure
Learning Curve (CUSUM)
Tidsramme: During the study procedure
For each participant, success/failure data will be used for analysis; this analysis will be considered exploratory. The number of endotracheal intubation attempts required to learn will be recorded in the data collection. Sequential intubation performance data will be analyzed using cumulative sum (CUSUM) analysis.
During the study procedure

Samarbeidspartnere og etterforskere

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

Sponsor

Huseyin Cahit Halhalli, MD

Samarbeidspartnere

Health Institutes of Turkey

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 (Antatt)

15. oktober 2026

Primær fullføring (Antatt)

30. november 2026

Studiet fullført (Antatt)

15. desember 2026

Datoer for studieregistrering

Først innsendt

31. juli 2026

Først innsendt som oppfylte QC-kriteriene

31. juli 2026

Først lagt ut (Faktiske)

5. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • ITBP-2026-01

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Anonymized individual participant data (IPD) that comprise the published results will be shared. The shared data will include participant characteristics, randomization order, intubation performance measures (time to successful intubation, success on first attempt, difficulty rating, complications), and variables comprising primary and secondary analyses. No personal information will be included.

IPD-delingstidsramme

Beginning 6 months after publication.

Tilgangskriterier for IPD-deling

Data will be provided to the relevant author upon reasonable request for scientifically valid research purposes. Access will be granted only after requests have been reviewed and approved by all researchers and a data usage agreement has been signed.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ANALYTIC_CODE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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