Airway ObstructionNCT02224027
Comparison of Laryngeal Mask and I-gel to Laryngoscope by Novice Operators in Simulated Difficult Airway
A study testing proceal laryngeal mask airway, tracheal tube and i-gel in people with Airway Obstruction, run by Yeungnam University College of Medicine at 1 site in South Korea.
Trial summary
The use of laryngeal mask airway or i-gel to manage airway may improve success rates, especially in difficult situations more than tracheal intubation. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Airway Obstruction
- What is being tested?
- proceal laryngeal mask airway, tracheal tube and i-gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2014to Dec 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- medical student
- nurse
- no experience of insertion using tracheal tube, i-gel, and laryngeal mask airway
Who cannot join
- experience of insertion using tracheal tube, i-gel, and laryngeal mask airway
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Pain Medicine, Yeungnam University hospital
Daegu, 705-035
Duckhee Lee, M.D., 82-53-620-3365, apsj0718@yu.ac.kr
Sangjin Park, M.D.
About this study
Official title: Comparison of Proceal Laryngeal Mask Airway and I-gel to Machintoch Laryngoscope by Novice Operators in Simulated Difficult Airway - a Manikin Study.
The use of laryngeal mask airway or i-gel to manage airway may improve success rates, especially in difficult situations more than tracheal intubation.
Read the detailed description
This study compares the insertion success rate and insertion time among the proceal laryngeal mask airway, i-gel, and tracheal tube. Following a short lecture, airway novices try to insert proceal laryngeal mask airway, i-gel, and tracheal tube into manikin with difficult laryngoscopy scenarios.
- Conditions
- Airway Obstruction
- Being tested
- proceal laryngeal mask airway, tracheal tube, i-gel
- Medical subject headings
- Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proceal laryngeal mask airwayDevice
Also called LMA proceal
In proceal laryngeal mask group, proceal laryngeal mask airway is inserted by novices.
tracheal tubeDevice
Also called TaperGuard
In tracheal tube group, tracheal tube is intubated by novices.
i-gelDevice
In i-gel group, i-gel is inserted by novices.
| Study group | Role | What they receive |
|---|---|---|
| i-gel | Active comparator | Each novice performs i-gel insertion in difficult laryngoscopy scenario. Receives: Device: i-gel |
| proceal laryngeal mask airway | Active comparator | Each novice performs proceal laryngeal mask airway insertion in difficult laryngoscopy scenario. Receives: Device: proceal laryngeal mask airway |
| tracheal tube | Active comparator | Each novice performs tracheal intubation in difficult laryngoscopy scenario. Receives: Device: tracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time of successful laryngeal mask, i-gel, or tracheal tube insertion attempt
A blinded observer records the time of successful laryngeal mask, i-gel, or tracheal tube insertion attempt.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ObstructionStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 109 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yeungnam University College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sangjin Park, Yeungnam University College of Medicine
- Investigators
- Sangjin Park, M.D., Principal investigator, Department of Anesthesiology and Pain Medicine, College of medicine, Yeungnam University, Daemyung-Dong, Nam-Gu, Daegu, Republic of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02224027
- Sponsor's protocol ID
- apsj0821
- Status last verified
- Dec 2015
- First submitted
- 21 Aug 2014
- Last updated
- 30 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Proceal Laryngeal Mask Airway and I-gel to Machintoch Laryngoscope by Novice Operators in Simulated Difficult Airway - a Manikin Study.
- ClinicalTrials.gov ID
- NCT02224027
- Acronym / sponsor ID
- apsj0821
- Conditions
- Airway Obstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 109 participants (estimated)
- Lead sponsor
- Yeungnam University College of MedicineUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 22 Aug 2014 (estimated)
- 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.
The use of laryngeal mask airway or i-gel to manage airway may improve success rates, especially in difficult situations more than tracheal intubation.
Detailed description
This study compares the insertion success rate and insertion time among the proceal laryngeal mask airway, i-gel, and tracheal tube. Following a short lecture, airway novices try to insert proceal laryngeal mask airway, i-gel, and tracheal tube into manikin with difficult laryngoscopy scenarios.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| i-gel | Active comparator | Device: i-gelEach novice performs i-gel insertion in difficult laryngoscopy scenario. |
| proceal laryngeal mask airway | Active comparator | Device: proceal laryngeal mask airwayEach novice performs proceal laryngeal mask airway insertion in difficult laryngoscopy scenario. |
| tracheal tube | Active comparator | Device: tracheal tubeEach novice performs tracheal intubation in difficult laryngoscopy scenario. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- medical student
- nurse
- no experience of insertion using tracheal tube, i-gel, and laryngeal mask airway
Key exclusion criteria (1 listed)
- experience of insertion using tracheal tube, i-gel, and laryngeal mask airway
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 |
|---|---|---|
| proceal laryngeal mask airwayAlso: LMA procealIn proceal laryngeal mask group, proceal laryngeal mask airway is inserted by novices. | Device | proceal laryngeal mask airway |
| tracheal tubeAlso: TaperGuardIn tracheal tube group, tracheal tube is intubated by novices. | Device | tracheal tube |
| i-gelIn i-gel group, i-gel is inserted by novices. | Device | i-gel |
Primary outcome
the time of successful laryngeal mask, i-gel, or tracheal tube insertion attempt
Time frame: intraoperative
A blinded observer records the time of successful laryngeal mask, i-gel, or tracheal tube insertion attempt.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2015.
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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.
Sangjin Park, M.D. principal investigator
Department of Anesthesiology and Pain Medicine, College of medicine, Yeungnam University, Daemyung-Dong, Nam-Gu, Daegu, Republic of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing proceal laryngeal mask airway, tracheal tube and i-gel in people with Airway Obstruction, run by Yeungnam University College of Medicine at 1 site in South Korea.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Dec 2015. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sangjin Park, M.D. (82-53-620-3366, apsj0718@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the time of successful laryngeal mask, i-gel, or tracheal tube insertion attempt (time frame: intraoperative). 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 30 Dec 2015.