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 Contact

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of, 705-035
        • Recruiting
        • Department of Anesthesiology and Pain Medicine, Yeungnam University hospital
        • Principal Investigator:
          • Sangjin Park, M.D.
        • Contact:

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.
Device: i-gel
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.
Device: proceal laryngeal mask airway
In proceal laryngeal mask group, proceal laryngeal mask airway is inserted by novices.
Other Names:
  • LMA proceal
Active Comparator: tracheal tube
Each novice performs tracheal intubation in difficult laryngoscopy scenario.
Device: tracheal tube
In tracheal tube group, tracheal tube is intubated by novices.
Other Names:
  • TaperGuard

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.

Sponsor

Yeungnam University College of Medicine

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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