Novel Integrated Tube-Bougie Prototype for Endotracheal Intubation in Airway Simulation (ITBP)
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.
Przegląd badań
Status
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Huseyin Cahit Halhalli, MD
- Numer telefonu: +902622252700
- E-mail: huseyin.halhalli@sbu.edu.tr
Lokalizacje studiów
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Kocaeli
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Köseköy, Kocaeli, Turcja (Türkiye), 41060
- University of Health Sciences, Kocaeli City Hospital
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Kontakt:
- Huseyin Cahit Halhalli, MD
- Numer telefonu: +902622252700
- E-mail: huseyin.halhalli@sbu.edu.tr
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: EPATS
Participants will perform endotracheal intubation using the EPATS (Integrated Tube-Bougie Prototype) in both normal and difficult airway simulation scenarios.
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The novel integrated tube-bougie prototype developed for endotracheal intubation.
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Aktywny komparator: Standard Gum Elastic Bougie
Participants will perform endotracheal intubation using a standard gum elastic bougie in both normal and difficult airway simulation scenarios.
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Standard gum elastic bougie used as an intubation adjunct.
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Aktywny komparator: Standard Stylet
Participants will perform endotracheal intubation using a standard stylet in both normal and difficult airway simulation scenarios.
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Standard intubating stylet used as an intubation adjunct.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Time to successful endotracheal intubation
Ramy czasowe: During the study procedure
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The insertion and removal time (seconds) of the laryngoscope from the mouth will be recorded.
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During the study procedure
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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First Pass Success (FPS)
Ramy czasowe: During the study procedure
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Successful endotracheal intubation without removing the laryngoscope from the mouth.
Attempts exceeding 60 seconds will be considered unsuccessful.
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During the study procedure
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Difficulty Assessment (VAS)
Ramy czasowe: At the end of the study procedure
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The practitioner's difficulty perception will be measured using a 0-100 mm visual analog scale.
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At the end of the study procedure
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Complications (Dental trauma and Esophageal intubation)
Ramy czasowe: During the study procedure
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Complications for each procedure (dental trauma and esophageal intubation) will be determined by the researchers.
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During the study procedure
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Learning Curve (CUSUM)
Ramy czasowe: During the study procedure
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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.
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During the study procedure
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Współpracownicy i badacze
Sponsor
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- ITBP-2026-01
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Ramy czasowe udostępniania IPD
Kryteria dostępu do udostępniania IPD
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ANALITYCZNY_KOD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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