- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02224027
Comparison of Laryngeal Mask and I-gel to Laryngoscope by Novice Operators in Simulated Difficult Airway
December 28, 2015 updated by: Sangjin Park, Yeungnam University College of Medicine
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
109
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Daegu, Korea, Republic of, 705-035
- Recruiting
- Department of Anesthesiology and Pain Medicine, Yeungnam University hospital
-
Principal Investigator:
- Sangjin Park, M.D.
-
Contact:
- Duckhee Lee, M.D.
- Phone Number: 82-53-620-3365
- Email: apsj0718@yu.ac.kr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- medical student
- nurse
- no experience of insertion using tracheal tube, i-gel, and laryngeal mask airway
Exclusion Criteria:
- experience of insertion using tracheal tube, i-gel, and laryngeal mask airway
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: i-gel
Each novice performs i-gel insertion in difficult laryngoscopy scenario.
|
In i-gel group, i-gel is inserted by novices.
|
|
Active Comparator: proceal laryngeal mask airway
Each novice performs proceal laryngeal mask airway insertion in difficult laryngoscopy scenario.
|
In proceal laryngeal mask group, proceal laryngeal mask airway is inserted by novices.
Other Names:
|
|
Active Comparator: tracheal tube
Each novice performs tracheal intubation in difficult laryngoscopy scenario.
|
In tracheal tube group, tracheal tube is intubated by novices.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
intraoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sangjin Park, M.D., Department of Anesthesiology and Pain Medicine, College of medicine, Yeungnam University, Daemyung-Dong, Nam-Gu, Daegu, Republic of Korea
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Anticipated)
October 1, 2016
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
August 21, 2014
First Submitted That Met QC Criteria
August 21, 2014
First Posted (Estimate)
August 22, 2014
Study Record Updates
Last Update Posted (Estimate)
December 30, 2015
Last Update Submitted That Met QC Criteria
December 28, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- apsj0821
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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