NCT02224027

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 21, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 22, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 30, 2015

Status Verified

December 1, 2015

Enrollment Period

2.2 years

First QC Date

August 21, 2014

Last Update Submit

December 28, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

i-gel

ACTIVE COMPARATOR

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

Device: i-gel

proceal laryngeal mask airway

ACTIVE COMPARATOR

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

Device: proceal laryngeal mask airway

tracheal tube

ACTIVE COMPARATOR

Each novice performs tracheal intubation in difficult laryngoscopy scenario.

Device: tracheal tube

Interventions

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

Also known as: LMA proceal
proceal laryngeal mask airway

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

Also known as: TaperGuard
tracheal tube
i-gelDEVICE

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

i-gel

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • medical student
  • nurse
  • no experience of insertion using tracheal tube, i-gel, and laryngeal mask airway

You may not qualify if:

  • experience of insertion using tracheal tube, i-gel, and laryngeal mask airway

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Yeungnam University hospital

Daegu, 705-035, South Korea

RECRUITING

MeSH Terms

Conditions

Airway Obstruction

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract Diseases

Study Officials

  • Sangjin Park, M.D.

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sangjin Park, M.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

August 21, 2014

First Posted

August 22, 2014

Study Start

August 1, 2014

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

December 30, 2015

Record last verified: 2015-12

Locations