Blind Intubation Through the Tulip Airway Versus Direct Laryngoscopy
Comparison of Blind Endotracheal Intubation Through the Tulip Oropharyngeal Airway and Direct Laryngoscopy by Novice Operators: A Randomized Crossover Manikin Study
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This study is a randomized crossover mannequin-based simulation designed to compare two endotracheal intubation techniques performed by novice operators with limited or no prior intubation experience.
Participants will perform tracheal intubation using two different methods in a randomized order: (1) blind endotracheal intubation via the Tulip oropharyngeal airway, and (2) direct laryngoscopy. Each participant will serve as their own control in a crossover design, allowing direct comparison of the two techniques under standardized simulated airway conditions.
The primary objective is to compare the success rate of intubation between the two techniques. Secondary outcomes may include time to successful intubation, number of attempts, and ease of use, as assessed in a controlled simulation environment.
All procedures will be performed on airway mannequins in a simulation setting without involving human subjects or patient care. The study is intended to evaluate technical performance and feasibility in a standardized training environment, rather than clinical effectiveness in patients.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Ankara, Tyrkia (Türkiye), 06170
- Ankara Etlik City Hospital, Ministry of Health, Türkiye
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Voluntary participation in the study
- Anesthesia technician students with no prior airway management experience
- Age ≥ 18 years
- Willingness to participate in simulation-based intubation procedures
Exclusion Criteria:
- Prior advanced airway management experience (e.g., regular intubation practice in clinical settings)
- Refusal to participate or withdraw consent
- Inability to complete simulation procedures for any reason
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: Tulip Airway
Blind endotracheal intubation via Tulip oropharyngeal airway in a simulated mannequin environment.
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Endotracheal intubation via Tulip airway in a simulated mannequin setting.
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Aktiv komparator: Direct Laryngoscopy
Endotracheal intubation using standard direct laryngoscopy in a simulated mannequin environment.
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Standard endotracheal intubation using direct laryngoscopy.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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First-pass intubation success rate
Tidsramme: At each endotracheal intubation attempt during the single-day randomized crossover simulation session in a mannequin model
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Comparison of first-attempt success rate of endotracheal intubation using Tulip oropharyngeal airway versus direct laryngoscopy in a simulated mannequin setting performed by novice operators in a randomized crossover design.
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At each endotracheal intubation attempt during the single-day randomized crossover simulation session in a mannequin model
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Fethi Gültop, MD, Ankara Etlik City Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- tulip-2026
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
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