VentilationNCT05523752
Insertion of Different Supraglottic Airway Devices on Manikin
A study testing Proseal Laryngeal Mask, Classic Laryngeal Mask and I-gel in people with Ventilation and Airway Management, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
When tracheal intubation and face mask ventilation fail, and the insertion of supraglottic airway devices (SHA) can provide ventilation, protecting the patient from hypoxemia. Supraglottic airway devices have become an important part of difficult airway algorithms. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Ventilation, Airway Management, Education
- What is being tested?
- Proseal Laryngeal Mask, Classic Laryngeal Mask and I-gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 15 Aug 2022
- Phase
- Interventional
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Studying in medical school in term 5
- To have completed anesthesiology and reanimation internship
Who cannot join
- who do not want to participate in the study
- Students with previous experience with four airway devices
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Bülent Ecevit University
Zonguldak, Kozlu, 67600
About this study
Official title: Placement of Four Different Supraglottic Airway Devices by Medicine Faculty Students: A Manikin Study
When tracheal intubation and face mask ventilation fail, and the insertion of supraglottic airway devices (SHA) can provide ventilation, protecting the patient from hypoxemia. Supraglottic airway devices have become an important part of difficult airway algorithms. The European Resuscitation Council Guidelines recommend supraglottic airway devices for airway management by non-specialized healthcare providers. Education through simulators contributes to the development of students without direct contact with patients. In this study, it was aimed to compare the success of placement of four different supraglottic airway devices on the manikin of term 5 students who participate to the Anesthesiology and Reanimation internship.
- Conditions
- Ventilation, Airway Management, Education
- Being tested
- Proseal Laryngeal Mask, Classic Laryngeal Mask, I-gel, Suprema Laryngeal Mask
- Keywords
- Airway management, Supraglottic airway devices, Manikin study, education
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proseal Laryngeal MaskDevice
insertion of Proseal Laryngeal Mask
Classic Laryngeal MaskDevice
insertion of Classic Laryngeal Mask
I-gelDevice
insertion of I-gel
Suprema Laryngeal MaskDevice
insertion of Suprema Laryngeal Mask
| Study group | Role | What they receive |
|---|---|---|
| Proseal Laryngeal Mask | Other | Not described Receives: Device: Proseal Laryngeal Mask |
| Classic Laryngeal Mask | Other | Not described Receives: Device: Classic Laryngeal Mask |
| I-gel | Other | Not described Receives: Device: I-gel |
| Suprema Laryngeal Mask | Other | Not described Receives: Device: Suprema Laryngeal Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
difficulty of attempts
pointing the difficulty of insertion from 0 to 100
Measured: during insertion procedure
Secondary outcomes (2)
Time of attempts
time from insertion to ventilation
Measured: during insertion procedure
number of attempts
number of attempts for successfull placement
Measured: during insertion procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start1 Mar 2022
- Primary completion30 Jul 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VentilationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keziban Bollucuoglu, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523752
- Sponsor's protocol ID
- 2022/03-13
- Status last verified
- Aug 2022
- First submitted
- 16 Aug 2022
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placement of Four Different Supraglottic Airway Devices by Medicine Faculty Students: A Manikin Study
- ClinicalTrials.gov ID
- NCT05523752
- Acronym / sponsor ID
- 2022/03-13
- Conditions
- Ventilation, Airway Management, Education
- Keywords
- Airway management, Supraglottic airway devices, Manikin study, education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 31 Aug 2022 (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.
When tracheal intubation and face mask ventilation fail, and the insertion of supraglottic airway devices (SHA) can provide ventilation, protecting the patient from hypoxemia. Supraglottic airway devices have become an important part of difficult airway algorithms. The European Resuscitation Council Guidelines recommend supraglottic airway devices for airway management by non-specialized healthcare providers. Education through simulators contributes to the development of students without direct contact with patients. In this study, it was aimed to compare the success of placement of four different supraglottic airway devices on the manikin of term 5 students who participate to the Anesthesiology and Reanimation internship.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Proseal Laryngeal Mask | Other | Device: Proseal Laryngeal Mask |
| Classic Laryngeal Mask | Other | Device: Classic Laryngeal Mask |
| I-gel | Other | Device: I-gel |
| Suprema Laryngeal Mask | Other | Device: Suprema Laryngeal Mask |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Studying in medical school in term 5
- To have completed anesthesiology and reanimation internship
Key exclusion criteria (2 listed)
- who do not want to participate in the study
- Students with previous experience with four airway devices
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 |
|---|---|---|
| Proseal Laryngeal Maskinsertion of Proseal Laryngeal Mask | Device | Proseal Laryngeal Mask |
| Classic Laryngeal Maskinsertion of Classic Laryngeal Mask | Device | Classic Laryngeal Mask |
| I-gelinsertion of I-gel | Device | I-gel |
| Suprema Laryngeal Maskinsertion of Suprema Laryngeal Mask | Device | Suprema Laryngeal Mask |
Primary outcome
difficulty of attempts
Time frame: during insertion procedure
pointing the difficulty of insertion from 0 to 100
2 secondary outcomes
Time of attempts
Time frame: during insertion procedure
number of attempts
Time frame: during insertion procedure
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 31 Aug 2022.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proseal Laryngeal Mask, Classic Laryngeal Mask and I-gel in people with Ventilation and Airway Management, run by Zonguldak Bulent Ecevit University 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 2 inclusion and 2 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 31 Aug 2022. 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?
difficulty of attempts (time frame: during insertion procedure). 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 31 Aug 2022.