NCT03645174

Brief Summary

In difficult airway situation, fiberoptic-guided endotracheal intubation through laryngeal mask airway(LMA) is one of option. Aintree catheter is a device to help change LMA to endotracheal tube, but it needs complex and multiple process. Long endotracheal tube can solve this problem of Aintree catheter. The purpose of this study is proving the efficacy of long endotracheal tube compared to Aintree cathter in fiberoptic-guided intubation through LMA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 22, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2019

Completed
Last Updated

March 7, 2019

Status Verified

March 1, 2019

Enrollment Period

4 months

First QC Date

August 22, 2018

Last Update Submit

March 6, 2019

Conditions

Intubation;Difficult

Keywords

intubationAintreeLaryngeal mask airwayfiberoptic

Outcome Measures

Primary Outcomes (1)

  • Intubation time

    from entry of fiberoptic at LMA to Ambu bagging

    3 minutes

Secondary Outcomes (2)

  • Success rate

    5 minutes

  • Difficulty score

    5 minutes

Study Arms (2)

Aintree catheter

ACTIVE COMPARATOR

Fiberoptic-guided intubation through LMA, using Aintree catheter

Device: Aintree catheter

Long tube

EXPERIMENTAL

Fiberoptic-guided intubation through LMA, using long tube

Device: Using long tube

Interventions

Using long tubeDEVICE

Fiberoptic-guided intubation through LMA, using long tube

Long tube
Aintree catheterDEVICE

Fiberoptic-guided intubation through LMA, using Aintree catheter

Aintree catheter

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Residents of Anesthesiology
  • Who has less than 10 times of experience of fiberoptic intubation

You may not qualify if:

  • Who has more than 10 times of experience of fiberoptic intubation
  • Who deny participating in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou university school of medicine

Suwon, Gyeonggi-do, 16377, South Korea

Location

Related Publications (1)

  • Chae YJ, Lee H, Jun B, Yi IK. Conversion of I-gel to definitive airway in a cervical immobilized manikin: Aintree intubation catheter vs long endotracheal tube. BMC Anesthesiol. 2020 Jun 18;20(1):152. doi: 10.1186/s12871-020-01069-9.

    PMID: 32552828DERIVED

Study Officials

  • In Kyong Yi, MD

    Ajou University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Manikin model Intubators are residents of Anesthesiology
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assitant professor

Study Record Dates

First Submitted

August 22, 2018

First Posted

August 24, 2018

Study Start

September 1, 2018

Primary Completion

December 31, 2018

Study Completion

January 15, 2019

Last Updated

March 7, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

only for personally requested

Locations

KR(1)