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

Airway Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02224027
• Other study ID #: apsj0821
• Status: Recruiting
• Phase: N/A
• First received: August 21, 2014
• Last updated: December 28, 2015
• Start date: August 2014
• Est. completion date: December 2016

Study information

• Verified date: December 2015
• Source: Yeungnam University College of Medicine
• Contact: Sangjin Park, M.D.
• Phone: 82-53-620-3366
• Email: apsj0718[@]naver.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 109
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Airway Obstruction

Intervention

Device:
• proceal laryngeal mask airway
In proceal laryngeal mask group, proceal laryngeal mask airway is inserted by novices.
• tracheal tube
In tracheal tube group, tracheal tube is intubated by novices.
• i-gel
In i-gel group, i-gel is inserted by novices.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Yeungnam University hospital	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Yeungnam University College of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	intraoperative	No