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临床试验/NCT04866446
NCT04866446已完成不适用

Evaluation of The Effects of Personal Protective Equipment During Airway Management; A Prospective, Non-randomized, Controlled, Simulation Study

Kezban Aydan Okuyucu1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2021年2月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3
试验地点
1
主要终点
Evaluation of times

研究概览

简要总结

Covid-19 disease has caused a worldwide pandemic. However, it was necessary to reduce the transmission of the disease as much as possible. The highest risk of transmission is airway management. Medical personnel responsible for airway management are at the greatest risk. One of the most important ways to protect anesthetists from contamination is to use PPE. But, it should be considered that there is some disadvantage about using PPE. The investigators aimed to evaluate the effects of the use of personal protective equipment and standard uniform during airway management.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Being an anesthesiology resident, specialist or nurse

排除标准

  • Anxiety Disorder
  • Severe heart or lung disease
  • Claustrophobia

结局指标

主要结局

Evaluation of times

时间窗: 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.

Evaluation of number of attempts

时间窗: 2 minutes

For both intubation and laryngeal mask airway insertion, number of attempts until ventilation

Evaluation of presence of optimisation maneuver

时间窗: 30 seconds

Whether there is optimisation maneuver for each attempt whether there is maneuver for each attempt

Evaluation of Modified Cormack/Lehane classification

时间窗: 30 seconds

The classification includes 5 grades; grade 1, 2a, 2b, 3 and 4. Grade 1 defines the best image of glottis.

Evaluation of Percentage of Glottic Opening Scores

时间窗: 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.

次要结局

  • Visual Analog Scale of using personal protective equipment(15 minutes)

研究者

发起方
Kezban Aydan Okuyucu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kezban Aydan Okuyucu

Medical Doctor

Saglik Bilimleri Universitesi

研究点 (1)

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