NCT04866446

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

February 5, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2021

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 29, 2021

Completed
Last Updated

April 29, 2021

Status Verified

April 1, 2021

Enrollment Period

Same day

First QC Date

January 6, 2021

Last Update Submit

April 26, 2021

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (1)

  • Visual Analog Scale of using personal protective equipment

    15 minutes

Study Arms (4)

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

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

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

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

Interventions

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

difficult airway manikin with personal protective equipmentdifficult airway manikin with standard uniformnormal airway manikin with personal protective equipmentnormal airway manikin with standard uniform

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Being an anesthesiology resident, specialist or nurse

You may not qualify if:

  • Anxiety Disorder
  • Severe heart or lung disease
  • Claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aydan Okuyucu

Kocaeli, Kocaeli̇, 41900, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsIntubationInvestigative Techniques

Study Officials

  • Mehmet Yilmaz, 2

    University of Healt Sciences, Kocaeli Derince Education and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

January 6, 2021

First Posted

April 29, 2021

Study Start

February 5, 2021

Primary Completion

February 5, 2021

Study Completion

February 7, 2021

Last Updated

April 29, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations