Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

31. august 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Tyrkiet (Türkiye)
    • Kocaeli
      • Köseköy, Kocaeli, Tyrkiet (Türkiye), 41060
        • University of Health Sciences, Kocaeli City Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde 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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: EPATS
Participants will perform endotracheal intubation using the EPATS (Integrated Tube-Bougie Prototype) in both normal and difficult airway simulation scenarios.
Enhed: 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.
Enhed: 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.
Enhed: Standard stylet
Standard intubating stylet used as an intubation adjunct.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Huseyin Cahit Halhalli, MD

Samarbejdspartnere

Health Institutes of Turkey

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. oktober 2026

Primær færdiggørelse (Anslået)

30. november 2026

Studieafslutning (Anslået)

15. december 2026

Datoer for studieregistrering

Først indsendt

31. juli 2026

Først indsendt, der opfyldte QC-kriterier

31. juli 2026

Først opslået (Faktiske)

5. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • ITBP-2026-01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (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.

IPD-delingsadgangskriterier

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 Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner