Personal Protective EquipmentNCT04866446
Evaluation of The Effects of Personal Protective Equipment During Airway Management
An observational study of Personal Protective Equipment and Airway Management, run by Kezban Aydan Okuyucu at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Personal Protective Equipment, Airway Management
- What is being tested?
- endotracheal intubation and laringeal mask airway insertion
- Type of treatment
- Medical device
- How many people
- 3 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Feb 2021to 7 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Anesthesiology residents, anesthesiology specialists or anesthesia nurses will be participants in this study.
Who may be able to join
- Being an anesthesiology resident, specialist or nurse
Who cannot join
- Anxiety Disorder
- Severe heart or lung disease
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Personal Protective Equipment, Airway Management
- Being tested
- endotracheal intubation and laringeal mask airway insertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endotracheal intubation and laringeal mask airway insertionDevice
endotracheal intubation and laringeal mask airway insertion on the airway manikin with different devices
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: endotracheal intubation and laringeal mask airway insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 minutes
Evaluation of number of attempts
For both intubation and laryngeal mask airway insertion, number of attempts until ventilation
Measured: 2 minutes
Evaluation of presence of optimisation maneuver
Whether there is optimisation maneuver for each attempt whether there is maneuver for each attempt
Measured: 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.
Measured: 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.
Measured: 30 seconds
Secondary outcomes (1)
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.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start5 Feb 2021
- Primary completion5 Feb 2021
- Study completion7 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Personal Protective EquipmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kezban Aydan Okuyucu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kezban Aydan Okuyucu, Saglik Bilimleri Universitesi
- Investigators
- Mehmet Yilmaz, 2, Study director, University of Healt Sciences, Kocaeli Derince Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866446
- Sponsor's protocol ID
- derinceanesteziaydan-1
- Status last verified
- Apr 2021
- First submitted
- 6 Jan 2021
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Effects of Personal Protective Equipment During Airway Management; A Prospective, Non-randomized, Controlled, Simulation Study
- ClinicalTrials.gov ID
- NCT04866446
- Acronym / sponsor ID
- derinceanesteziaydan-1
- Conditions
- Personal Protective Equipment, Airway Management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Kezban Aydan OkuyucuUniversity, hospital or other
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 5 Feb 2021 (actual)
- Study completion
- 7 Feb 2021 (actual)
- First posted
- 29 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| normal airway manikin with standard uniform | – | Device: endotracheal intubation and laringeal mask airway insertionThe 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. |
| normal airway manikin with personal protective equipment | – | Device: endotracheal intubation and laringeal mask airway insertionThe 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. |
| difficult airway manikin with standard uniform | – | Device: endotracheal intubation and laringeal mask airway insertionThe 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. |
| difficult airway manikin with personal protective equipment | – | Device: endotracheal intubation and laringeal mask airway insertionThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Anesthesiology residents, anesthesiology specialists or anesthesia nurses will be participants in this study.
Key inclusion criteria (1 listed)
- Being an anesthesiology resident, specialist or nurse
Key exclusion criteria (3 listed)
- Anxiety Disorder
- Severe heart or lung disease
- Claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endotracheal intubation and laringeal mask airway insertionendotracheal intubation and laringeal mask airway insertion on the airway manikin with different devices | Device | difficult airway manikin with personal protective equipment, difficult airway manikin with standard uniform, normal airway manikin with personal protective equipment, normal airway manikin with standard uniform |
Primary outcome
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.
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.
Evaluation of number of attempts
Time frame: 2 minutes
For both intubation and laryngeal mask airway insertion, number of attempts until ventilation
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
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.
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.
1 secondary outcome
Visual Analog Scale of using personal protective equipment
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet Yilmaz, 2 study director
University of Healt Sciences, Kocaeli Derince Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Personal Protective Equipment and Airway Management, run by Kezban Aydan Okuyucu at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of times (time frame: 2 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.