Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of The Effects of Personal Protective Equipment During Airway Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04866446
Recruitment Status : Completed
First Posted : April 29, 2021
Last Update Posted : April 29, 2021
Sponsor:
Information provided by (Responsible Party):
Kezban Aydan Okuyucu, Saglik Bilimleri Universitesi

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Personal Protective Equipment Airway Management 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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 3 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of The Effects of Personal Protective Equipment During Airway Management; A Prospective, Non-randomized, Controlled, Simulation Study
Actual Study Start Date : February 5, 2021
Actual Primary Completion Date : February 5, 2021
Actual Study Completion Date : February 7, 2021
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Anesthesiology residents, anesthesiology specialists or anesthesia nurses will be participants in this study.
Criteria

Inclusion Criteria:

  • Being an anesthesiology resident, specialist or nurse

Exclusion Criteria:

  • Anxiety Disorder
  • Severe heart or lung disease
  • Claustrophobia
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04866446


Locations
Layout table for location information
Turkey
Aydan Okuyucu
Kocaeli, Kocaeli̇, Turkey, 41900
Sponsors and Collaborators
Kezban Aydan Okuyucu
Investigators
Layout table for investigator information
Study Director: Mehmet Yilmaz, 2 University of Healt Sciences, Kocaeli Derince Education and Research Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Kezban Aydan Okuyucu, Medical Doctor, Saglik Bilimleri Universitesi
ClinicalTrials.gov Identifier: NCT04866446    
Other Study ID Numbers: derinceanesteziaydan-1
First Posted: April 29, 2021    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No