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Completed

NCT Number: NCT04866446

Evaluation of The Effects of Personal Protective Equipment During Airway Management

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.

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Key information

Conditions

Personal Protective Equipment Airway Management

Sex eligibility

All sexes

Study type

Observational

Primary location

Aydan Okuyucu

Kocaeli, Kocaeli̇, 41900, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being an anesthesiology resident, specialist or nurse

Exclusion criteria

  • Anxiety Disorder
  • Severe heart or lung disease
  • Claustrophobia

Treatment and study plan

endotracheal intubation and laringeal mask airway insertion

Device

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

Primary outcomes

  1. Evaluation of times

    Time frame: 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. Evaluation of times

    Time frame: 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.

  3. Evaluation of number of attempts

    Time frame: 2 minutes

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

  4. Evaluation of presence of optimisation maneuver

    Time frame: 30 seconds

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

  5. Evaluation of Modified Cormack/Lehane classification

    Time frame: 30 seconds

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

  6. Evaluation of Percentage of Glottic Opening Scores

    Time frame: 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.

Secondary outcomes

  1. Visual Analog Scale of using personal protective equipment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kezban Aydan Okuyucu

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 29, 2021
Registry last updated
Apr 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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