- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02290249
Intubation of a Pediatric Manikin in Difficult Airway by Novice Personnel: A Comparison of Glidescope and Airtraq
Face-to-face Intubation With Glidescope or Airtraq
Background and aims: Glidescope and Airtraq were designed to facilitate intubation and to improve teaching intubation. The investigators want to find their efficacy in normal airway, tongue edema and face-to-face orotracheal intubation models by novice personal.
Material and Methods: After Kocaeli Human Researches Ethics Committee approval, thirty six medical students who were on the beginning of their third year were enrolled in this study. After watching a video about the intubation of one of these devices, they attempted to intubate an adult manikin in three different airway models in a random order; first in normal airway, second, tongue edema and finally, in an entrapped manikin by face-to-face approach with Glidescope or Airtraq. Intubation attempts, insertion and intubation times, success rates, Cormack-Lehane grades, need of maneuvers of these devices were recorded.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- medical students at their third year,
- novice personnel
Exclusion Criteria:
- anesthesists,
- anesthesia residents,
- skilled investigators of tracheal intubation
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: normal airway
İntubation with glidescope or airtraq in normal airway
|
Manikin was intubated by different novice personal with glidescope videolaryngoscope
Pediatric manikin was intubated by novice personal with airtraq
|
Aktiv komparator: tongue edema
intubation with glidescope or airtraq in tongue edema simulation
|
Manikin was intubated by different novice personal with glidescope videolaryngoscope
Pediatric manikin was intubated by novice personal with airtraq
|
Aktiv komparator: face-to-face
intubation with glidescope or airtraq in face-to-face intubation
|
Manikin was intubated by different novice personal with glidescope videolaryngoscope
Pediatric manikin was intubated by novice personal with airtraq
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
intubation success rates
Tidsramme: 5 minutes
|
We recorded the first and total intubation success rates of the intubation with one of these devices
|
5 minutes
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
intubation time
Tidsramme: 5 minutes
|
from the handling of the device till viewing the endotracheal tube entering the vocal cords
|
5 minutes
|
Esophageal intubation
Tidsramme: 5 minutes
|
is there an esophageal intubation occurred while inserting the tube or not
|
5 minutes
|
need of optimisation maneuvers
Tidsramme: 5 minutes
|
do we need an optimization maneuver while intubating or while viewing the glottis or not
|
5 minutes
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Zehra I ARSLAN, Doctor, Anesthesiology and Reanimation
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- KOU KAEK 2014/145
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