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Comparison of Laryngeal Mask and I-gel to Laryngoscope by Novice Operators in Simulated Difficult Airway

Primary Purpose

Airway Obstruction

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

proceal laryngeal mask airway

tracheal tube

i-gel

About this trial

This is an interventional supportive care trial for Airway Obstruction

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Department of Anesthesiology and Pain Medicine, Yeungnam University hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

i-gel

proceal laryngeal mask airway

tracheal tube

Arm Description

Each novice performs i-gel insertion in difficult laryngoscopy scenario.

Each novice performs proceal laryngeal mask airway insertion in difficult laryngoscopy scenario.

Each novice performs tracheal intubation in difficult laryngoscopy scenario.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02224027

First Posted

August 21, 2014

Last Updated

December 28, 2015

Sponsor

Yeungnam University College of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02224027

Brief Title

Comparison of Laryngeal Mask and I-gel to Laryngoscope by Novice Operators in Simulated Difficult Airway

Official Title

Comparison of Proceal Laryngeal Mask Airway and I-gel to Machintoch Laryngoscope by Novice Operators in Simulated Difficult Airway - a Manikin Study.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Unknown status

Study Start Date

August 2014 (undefined)

Primary Completion Date

October 2016 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Yeungnam University College of Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Airway Obstruction

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

Outcomes Assessor

Allocation

Non-Randomized

Enrollment

109 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

i-gel

Arm Type

Active Comparator

Arm Description

Each novice performs i-gel insertion in difficult laryngoscopy scenario.

Arm Title

proceal laryngeal mask airway

Arm Type

Active Comparator

Arm Description

Each novice performs proceal laryngeal mask airway insertion in difficult laryngoscopy scenario.

Arm Title

tracheal tube

Arm Type

Active Comparator

Arm Description

Each novice performs tracheal intubation in difficult laryngoscopy scenario.

Intervention Type

Device

Intervention Name(s)

proceal laryngeal mask airway

Other Intervention Name(s)

LMA proceal

Intervention Description

In proceal laryngeal mask group, proceal laryngeal mask airway is inserted by novices.

Intervention Type

Device

Intervention Name(s)

tracheal tube

Other Intervention Name(s)

TaperGuard

Intervention Description

In tracheal tube group, tracheal tube is intubated by novices.

Intervention Type

Device

Intervention Name(s)

i-gel

Intervention Description

In i-gel group, i-gel is inserted by novices.

Primary Outcome Measure Information:

Title

the time of successful laryngeal mask, i-gel, or tracheal tube insertion attempt

Description

A blinded observer records the time of successful laryngeal mask, i-gel, or tracheal tube insertion attempt.

Time Frame

intraoperative

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sangjin Park, M.D.

Phone

82-53-620-3366

apsj0718@naver.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sangjin Park, M.D.

Organizational Affiliation

Department of Anesthesiology and Pain Medicine, College of medicine, Yeungnam University, Daemyung-Dong, Nam-Gu, Daegu, Republic of Korea

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Anesthesiology and Pain Medicine, Yeungnam University hospital

City

Daegu

ZIP/Postal Code

705-035

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Duckhee Lee, M.D.

Phone

82-53-620-3365

apsj0718@yu.ac.kr

First Name & Middle Initial & Last Name & Degree

Sangjin Park, M.D.

12. IPD Sharing Statement

Learn more about this trial

Comparison of Laryngeal Mask and I-gel to Laryngoscope by Novice Operators in Simulated Difficult Airway

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