Clinical trial NCT04866446: Evaluation of The Effects of Personal Protective Equipment During Airway Management
Official title: Evaluation of The Effects of Personal Protective Equipment During Airway Management; A Prospective, Non-randomized, Controlled, Simulation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Personal Protective Equipment
Airway Management
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 3
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Anesthesiology residents, anesthesiology specialists or anesthesia nurses will be participants in this study.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Being an anesthesiology resident, specialist or nurse

Exclusion Criteria:

* Anxiety Disorder
* Severe heart or lung disease
* Claustrophobia

Primary outcomes:
measure: Evaluation of times
timeFrame: 2 minutes
measure: Evaluation of times
timeFrame: 4 minutes
measure: Evaluation of number of attempts
timeFrame: 2 minutes
measure: Evaluation of presence of optimisation maneuver
timeFrame: 30 seconds
measure: Evaluation of Modified Cormack/Lehane classification
timeFrame: 30 seconds
measure: Evaluation of Percentage of Glottic Opening Scores
timeFrame: 30 seconds
Secondary outcomes:
measure: Visual Analog Scale of using personal protective equipment
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Aydan Okuyucu
state: Kocaeli̇
Study officials:
affiliation: University of Healt Sciences, Kocaeli Derince Education and Research Hospital
name: Mehmet Yilmaz, 2
role: STUDY_DIRECTOR
References: