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

31 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Geschat)

40

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Turkije (Türkiye)
    • Kocaeli
      • Köseköy, Kocaeli, Turkije (Türkiye), 41060
        • University of Health Sciences, Kocaeli City Hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: EPATS
Participants will perform endotracheal intubation using the EPATS (Integrated Tube-Bougie Prototype) in both normal and difficult airway simulation scenarios.
Apparaat: EPATS (Integrated Tube-Bougie Prototype)
The novel integrated tube-bougie prototype developed for endotracheal intubation.
Actieve vergelijker: Standard Gum Elastic Bougie
Participants will perform endotracheal intubation using a standard gum elastic bougie in both normal and difficult airway simulation scenarios.
Apparaat: Standard gum elastic bougie
Standard gum elastic bougie used as an intubation adjunct.
Actieve vergelijker: Standard Stylet
Participants will perform endotracheal intubation using a standard stylet in both normal and difficult airway simulation scenarios.
Apparaat: Standard stylet
Standard intubating stylet used as an intubation adjunct.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time to successful endotracheal intubation
Tijdsspanne: During the study procedure
The insertion and removal time (seconds) of the laryngoscope from the mouth will be recorded.
During the study procedure

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
First Pass Success (FPS)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Huseyin Cahit Halhalli, MD

Medewerkers

Health Institutes of Turkey

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

15 oktober 2026

Primaire voltooiing (Geschat)

30 november 2026

Studie voltooiing (Geschat)

15 december 2026

Studieregistratiedata

Eerst ingediend

31 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

31 juli 2026

Eerst geplaatst (Werkelijk)

5 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

2 september 2026

Laatste update ingediend die voldeed aan QC-criteria

31 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • ITBP-2026-01

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

Beginning 6 months after publication.

IPD-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ANALYTIC_CODE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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