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- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04866446
Evaluation of The Effects of Personal Protective Equipment During Airway Management
Evaluation of The Effects of Personal Protective Equipment During Airway Management; A Prospective, Non-randomized, Controlled, Simulation Study
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
Objective: The investigators aimed to compare the effects of the use of personal protective equipment and standard uniform during airway management using direct laryngoscope, GlideScope video laryngoscope, C-Mac video laryngoscope, I-gel laryngeal mask airway , ProSeal laryngeal mask airway and Frova intubation catheter on the manikin that created both difficult airway and normal airway conditions in the Department of Anesthesiology and Reanimation at the Derince Training and Research Hospital, University of Health Sciences.
Materials and Methods: The study will carry out with 24 participants in Health Sciences University Kocaeli Derince Health Education and Research Center. In the study, a simulation manikin will use to evaluate the effect of personal protective equipment use on airway management. Anesthesia technicians, anesthesia residents and specialists will include as participants. As demographic data, the clinical positions of the participants, their experiences with each airway method and the use of personal protective equipment, age, gender, height and weight information will be recorded. Each procedure will be explained to the participants by an anesthesiology specialist and a resident. Then the participants perform their procedure first with standard uniform and then by wearing personal protective equipment. Endotracheal intubation with direct laryngoscope, GlideScope video laryngoscope, C-Mac video laryngoscope and Frova intubation catheter followed by I-gel and ProSeal laryngeal mask airway will be used, respectively. Each procedure will be carried out by creating normal and difficult airway conditions, respectively. Time, number of attempts and presence of optimization maneuver will be recorded for each procedure. Modified CLS (Cormack Lehane Score) and POGO (Percentage Of Glottic Opening) scores will be also recorded during intubation procedures. Each participant will be asked to give a score between 1 and 100 using the Visual Analogue Scale (VAS) in order to evaluate the difficulty of intervention after each procedure subjectively and it will be recorded. Finally, the other subjective effects of personal protective equipment using on participants (such as sweating, feeling of warmth) will be asked.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Kocaeli̇
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Kocaeli, Kocaeli̇, Tacchino, 41900
- Aydan Okuyucu
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Being an anesthesiology resident, specialist or nurse
Exclusion Criteria:
- Anxiety Disorder
- Severe heart or lung disease
- Claustrophobia
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
normal airway manikin with standard uniform
The participants will carry out intubation procedure using macintosh direct laryngoscope, GlideScope video laryngoscope, C-Mac video laryngoscope and Frova intubation catheter and laryngeal mask insertion using ProSeal LMA and I-gel LMA, respectively.
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endotracheal intubation and laringeal mask airway insertion on the airway manikin with different devices
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normal airway manikin with personal protective equipment
The participants will carry out intubation procedure using macintosh direct laryngoscope, GlideScope video laryngoscope, C-Mac video laryngoscope and Frova intubation catheter and laryngeal mask insertion using ProSeal LMA and I-gel LMA, respectively.
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endotracheal intubation and laringeal mask airway insertion on the airway manikin with different devices
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difficult airway manikin with standard uniform
The participants will carry out intubation procedure using macintosh direct laryngoscope, GlideScope video laryngoscope, C-Mac video laryngoscope and Frova intubation catheter and laryngeal mask insertion using ProSeal LMA and I-gel LMA, respectively.
|
endotracheal intubation and laringeal mask airway insertion on the airway manikin with different devices
|
|
difficult airway manikin with personal protective equipment
The participants will carry out intubation procedure using macintosh direct laryngoscope, GlideScope video laryngoscope, C-Mac video laryngoscope and Frova intubation catheter and laryngeal mask insertion using ProSeal LMA and I-gel LMA, respectively.
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endotracheal intubation and laringeal mask airway insertion on the airway manikin with different devices
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Evaluation of times
Lasso di tempo: 2 minutes
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For intubations from holding the laryngoscope to ventilation, for laryngeal mask airway insertion from holding the laryngeal mask airway to ventilation For intubation time from holding the laryngoscope to observing glottic opening for standard uniform.
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2 minutes
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Evaluation of times
Lasso di tempo: 4 minutes
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For intubations from holding the laryngoscope to ventilation, for laryngeal mask airway insertion from holding the laryngeal mask airway to ventilation For intubation time from holding the laryngoscope to observing the glottic opening for personal protective equipment.
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4 minutes
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Evaluation of number of attempts
Lasso di tempo: 2 minutes
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For both intubation and laryngeal mask airway insertion, number of attempts until ventilation
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2 minutes
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Evaluation of presence of optimisation maneuver
Lasso di tempo: 30 seconds
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Whether there is optimisation maneuver for each attempt whether there is maneuver for each attempt
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30 seconds
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Evaluation of Modified Cormack/Lehane classification
Lasso di tempo: 30 seconds
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The classification includes 5 grades; grade 1, 2a, 2b, 3 and 4. Grade 1 defines the best image of glottis.
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30 seconds
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Evaluation of Percentage of Glottic Opening Scores
Lasso di tempo: 30 seconds
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Percentage of Glottic Opening describes the percentage of the glottic opening as percentages (0-100).
Number 100 describes that the participants see all glottic openings.
Number 0 describes that nothing is seen.
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30 seconds
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Visual Analog Scale of using personal protective equipment
Lasso di tempo: 15 minutes
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The visual analog scale is a scale that converts a subjective property to digital data.
It has values between 0-100.
Generally it is used for describing pain level.
But it is used for describing the difficulty of attempts in this study.
Number 0 explains that the attempt is very easy and number 100 is very difficult.
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15 minutes
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Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Mehmet Yilmaz, 2, University of Healt Sciences, Kocaeli Derince Education and Research Hospital
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- derinceanesteziaydan-1
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