Learning Curve of Fiberoptic Intubation Through Supraglottic Airway Device

September 22, 2021 updated by: Ji-Hyun Lee, Seoul National University Hospital

Learning Curve of Fiberoptic-guided Tracheal Intubation Through Supraglottic Airway Device for Pediatric Difficult Airway Manikin

This study aims to obtain learning curve data of residents for fiberoptic-guided tracheal intubation through supraglottic airway device for pediatric difficult airway manikin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Residents under anesthesiology training will undergo a simulation practice to a pediatric airway manikin, after a single demonstration by an expert for fiberoptic-guided tracheal intubation through supraglottic airway device. The participants will do the same practice 20 times to the same manikin.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Other
      • Seoul, Other, Korea, Republic of, 03080
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Residents under anesthesiology training with experience of more than 30 times of supraglottic airway device insertion and manipulation of fiberoptic bronchoscope

Exclusion Criteria:

  • Prior experience of fiberoptic-guided tracheal intubation through supraglottic airway device
  • Prior experience of training for fiberoptic-guided tracheal intubation through supraglottic airway device

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Candidates
Training of fiberoptic-guided tracheal intubation through supraglottic airway device to pediatric airway manikin
Other: Training
20-times training of fiberoptic-guided tracheal intubation through supraglottic airway device to pediatric airway manikin
Device: supraglottic airway device
supraglottic airway device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Elapsed time to succeed endotracheal intubation for each training period
Time Frame: From start of each training period to success of endotracheal intubation, not to exceed 10 minutes
From start of each training period to success of endotracheal intubation, not to exceed 10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Elapsed time to successful insertion of supraglottic airway device and ventilation of the manikin for each training period
Time Frame: From start of each training period to success of ventilation, not to exceed 10 minutes
From start of each training period to success of ventilation, not to exceed 10 minutes
Elapsed time to identification of vocal cords via fiberoptic bronchoscope for each training period
Time Frame: From start of each training period to identification of vocal cords, not to exceed 10 minutes
From start of each training period to identification of vocal cords, not to exceed 10 minutes
Elapsed time to introduction of fiberoptic bronchoscope into the trachea for each training period
Time Frame: From start of each training period to introduction of fiberoptic bronchoscope into the trachea, not to exceed 10 minutes
From start of each training period to introduction of fiberoptic bronchoscope into the trachea, not to exceed 10 minutes
Success rate of endotracheal intubation for each training period
Time Frame: From start of each training period to success of endotracheal intubation, not to exceed 10 minutes
From start of each training period to success of endotracheal intubation, not to exceed 10 minutes
Number of trials
Time Frame: From start of each training period to success of endotracheal intubation, not to exceed 10 minutes
Number of trials to succeed ventilation, vocal cord identification, fiberoptic bronchoscope introduction, endotracheal intubation for each training period
From start of each training period to success of endotracheal intubation, not to exceed 10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Ji-Hyun Lee, M.D., Ph.D., Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2020

Primary Completion (Actual)

July 22, 2021

Study Completion (Actual)

August 31, 2021

Study Registration Dates

First Submitted

July 19, 2020

First Submitted That Met QC Criteria

July 21, 2020

First Posted (Actual)

July 22, 2020

Study Record Updates

Last Update Posted (Actual)

September 23, 2021

Last Update Submitted That Met QC Criteria

September 22, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2006-160-1135

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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