NCT02811562

Brief Summary

Acquisition of knowledge and skills pertinent to the use of fibreoptic endoscopy is an important part of training in various medical and surgical specialties such as anesthesiology, emergency medicine, otolaryngology, and pulmonary medicine. It has been shown that there is a wide variation in the learning curves of residents and the number of attempts to achieve proficiency in performing upper airway endoscopy. recently, combined use of fiberoptic bronchoscope and videolaryngoscope has been suggested to be a good alternative. So, the aim of this study is to compare the number of attempt to achieve proficiency using fiberoptic bronchoscope alone or fiberoptic bronchoscope with Pentax-AWS.

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Longer than P75 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

First Submitted

Initial submission to the registry

June 16, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 23, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

July 13, 2020

Status Verified

July 1, 2020

Enrollment Period

6.4 years

First QC Date

June 16, 2016

Last Update Submit

July 10, 2020

Conditions

Difficult Airway

Outcome Measures

Primary Outcomes (1)

  • trial number to achieve 'proficient' in terms of cumulative sum analysis

    up to 2 weeks

Study Arms (2)

fiberoptic bronchoscope

ACTIVE COMPARATOR

Tracheal intubation in manikin using fiberoptic bronchoscope

Device: manikinDevice: fiberoptic bronchoscope

fiberoptic bronchoscope with pentax-airwayscope

EXPERIMENTAL

Tracheal intubation in manikin using fiberoptic bronchoscope with pentax-airwayscope

Device: manikinDevice: fiberoptic bronchoscopeDevice: pentax-airwayscope

Interventions

manikinDEVICE
fiberoptic bronchoscopefiberoptic bronchoscope with pentax-airwayscope
fiberoptic bronchoscopeDEVICE
fiberoptic bronchoscopefiberoptic bronchoscope with pentax-airwayscope
pentax-airwayscopeDEVICE
fiberoptic bronchoscope with pentax-airwayscope

Eligibility Criteria

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

You may qualify if:

  • resident in Department of anesthesiology

You may not qualify if:

  • resident who has an experience of successful fiberoptic bronchoscopic intubation in difficult case

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou universiry hospital

Suwon, Gyeonggi-do, 16499, South Korea

RECRUITING

Study Officials

  • Dae Hee Kim, MD

    Ajou University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dae Hee Kim, MD

CONTACT

82-10-3421-1022anekim@ajou.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

June 16, 2016

First Posted

June 23, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

July 13, 2020

Record last verified: 2020-07

Locations

KR(1)