- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Kocaeli̇
-
Kocaeli, Kocaeli̇, Pavo, 41900
- Aydan Okuyucu
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Being an anesthesiology resident, specialist or nurse
Exclusion Criteria:
- Anxiety Disorder
- Severe heart or lung disease
- Claustrophobia
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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.
|
endotracheal intubation and laringeal mask airway insertion on the airway manikin with different devices
|
|
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.
|
endotracheal intubation and laringeal mask airway insertion on the airway manikin with different devices
|
|
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.
|
endotracheal intubation and laringeal mask airway insertion on the airway manikin with different devices
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Evaluation of times
Periodo de tiempo: 2 minutes
|
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.
|
2 minutes
|
|
Evaluation of times
Periodo de tiempo: 4 minutes
|
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.
|
4 minutes
|
|
Evaluation of number of attempts
Periodo de tiempo: 2 minutes
|
For both intubation and laryngeal mask airway insertion, number of attempts until ventilation
|
2 minutes
|
|
Evaluation of presence of optimisation maneuver
Periodo de tiempo: 30 seconds
|
Whether there is optimisation maneuver for each attempt whether there is maneuver for each attempt
|
30 seconds
|
|
Evaluation of Modified Cormack/Lehane classification
Periodo de tiempo: 30 seconds
|
The classification includes 5 grades; grade 1, 2a, 2b, 3 and 4. Grade 1 defines the best image of glottis.
|
30 seconds
|
|
Evaluation of Percentage of Glottic Opening Scores
Periodo de tiempo: 30 seconds
|
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.
|
30 seconds
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Visual Analog Scale of using personal protective equipment
Periodo de tiempo: 15 minutes
|
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.
|
15 minutes
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Mehmet Yilmaz, 2, University of Healt Sciences, Kocaeli Derince Education and Research Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- derinceanesteziaydan-1
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .