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

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.

Study Overview

• Status: Completed
• Conditions: Airway Management; Personal Protective Equipment
• Intervention / Treatment: Device: endotracheal intubation and laringeal mask airway insertion

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.

• Study Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• Turkey
  • Kocaeli̇
    • Kocaeli, Kocaeli̇, Turkey, 41900
      • Aydan Okuyucu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Anesthesiology residents, anesthesiology specialists or anesthesia nurses will be participants in this study.

Description

Inclusion Criteria:

• Being an anesthesiology resident, specialist or nurse

Exclusion Criteria:

• Anxiety Disorder
• Severe heart or lung disease
• Claustrophobia

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: endotracheal intubation and laringeal mask airway insertion; 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.	Device: endotracheal intubation and laringeal mask airway insertion; 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.	Device: endotracheal intubation and laringeal mask airway insertion; 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.	Device: endotracheal intubation and laringeal mask airway insertion; endotracheal intubation and laringeal mask airway insertion on the airway manikin with different devices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of times	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	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	For both intubation and laryngeal mask airway insertion, number of attempts until ventilation	2 minutes
Evaluation of presence of optimisation maneuver	Whether there is optimisation maneuver for each attempt whether there is maneuver for each attempt	30 seconds
Evaluation of Modified Cormack/Lehane classification	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale of using personal protective equipment	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

Collaborators and Investigators

• Sponsor: Kezban Aydan Okuyucu
• Investigators: Study Director: Mehmet Yilmaz, 2, University of Healt Sciences, Kocaeli Derince Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2021
• Primary Completion (Actual): February 5, 2021
• Study Completion (Actual): February 7, 2021

Study Registration Dates

• First Submitted: January 6, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 29, 2021

Study Record Updates

• Last Update Posted (Actual): April 29, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: derinceanesteziaydan-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No