Evaluation of The Effects of Personal Protective Equipment During Airway Management

Airway Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04866446
• Other study ID #: derinceanesteziaydan-1
• Status: Completed
• Start date: February 5, 2021
• Est. completion date: February 7, 2021

Study information

• Verified date: April 2021
• Source: Saglik Bilimleri Universitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: February 7, 2021
• Est. primary completion date: February 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Being an anesthesiology resident, specialist or nurse

Exclusion Criteria:

• Anxiety Disorder

• Severe heart or lung disease

• Claustrophobia

Related Conditions & MeSH terms

• Airway Management
• Personal Protective Equipment

Intervention

Device:
• endotracheal intubation and laringeal mask airway insertion
endotracheal intubation and laringeal mask airway insertion on the airway manikin with different devices

Locations

Country	Name	City	State
Turkey	Aydan Okuyucu	Kocaeli	Kocaeli?

Sponsors (1)

Lead Sponsor	Collaborator
Kezban Aydan Okuyucu

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Evaluation of number of attempts	For both intubation and laryngeal mask airway insertion, number of attempts until ventilation	2 minutes
Primary	Evaluation of presence of optimisation maneuver	Whether there is optimisation maneuver for each attempt whether there is maneuver for each attempt	30 seconds
Primary	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
Primary	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	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