An Efficacy of Simulator Training for Fiberbronchoscopy in Intensivists

February 18, 2022 updated by: Jingyuan,Xu, Southeast University, China
We evaluated the effects of different fiberbronchoscopy training in how to teach and assess performance. Resident participants with no experience of fiberbronchoscopy, and doctors with little clinical experience with fiberbronchoscopy were eligible for the study.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants who passed the theory test were enrolled in the study, and two training simulators for fiberbronchoscopy were used. After randomization, participants were enrolled in Group A (Bronchoscopy training simulator LM-092 )and Group B(The BRONCH Mentor). The test will be taken after practice at the appropriate time.

Study Type

Interventional

Enrollment (Anticipated)

40

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

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Nanjing Zhongda Hospital, Southeast University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jingyuan Xu, MD
        • Sub-Investigator:
          • Yanjie Zhang

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Doctors with little experience of fiberbronchoscopy

Exclusion Criteria:

  • Resident participants who can not complete the study.
  • Resident participants who can not pass the theroy examination.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bronchoscopy training simulator
Bronchoscopy training simulator LM-092 (Koken Co., Ltd, Tokyo, Japan) was used to train the participants.
Device: Bronchoscopy training simulator LM-092 (Koken Co., Ltd, Tokyo, Japan)
Participants who passed the theory test and was enrolled in this group will use this device to practice. After the appropriate time of practice, the test will be taken to evaluate the efficacy.
Experimental: The BRONCH Mentor
Group B: The BRONCH Mentor (Simbionix, GI-Bronch Mentor, USA) was used.
Device: The BRONCH Mentor (Simbionix, GI-Bronch Mentor, USA)
Participants who passed the theory test and was enrolled in this group will use this device to practice. After the appropriate time of practice, the test will be taken to evaluate the efficacy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Final score for examination by Bronchoscopy training simulator
Time Frame: through study completion, an average of 3 months
Final score of manipulation, orientation, anatomy and actual operation
through study completion, an average of 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% time at mid-lumen for fiberbronchoscopy manipulation by Bronchoscopy training simulator
Time Frame: through study completion, an average of 3 months
% time at mid-lumen for fiberbronchoscopy manipulation by Bronchoscopy training simulator
through study completion, an average of 3 months
% time at mid-lumen
Time Frame: through study completion, an average of 3 months
% time at mid-lumen
through study completion, an average of 3 months
% time at mid-lumen for fiberbronchoscopy manipulation
Time Frame: through study completion, an average of 3 months
% time at mid-lumen for fiberbronchoscopy manipulation
through study completion, an average of 3 months
Total wall hits for fiberbronchoscopy manipulation by Bronchoscopy training simulator
Time Frame: through study completion, an average of 3 months
Total wall hits for fiberbronchoscopy manipulation by Bronchoscopy training simulator
through study completion, an average of 3 months

Collaborators and Investigators

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

Sponsor

Southeast University, China

Investigators

  • Study Director: Jingyuan Xu, M.D., Southeast university

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)

January 1, 2022

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

February 9, 2022

First Submitted That Met QC Criteria

February 18, 2022

First Posted (Actual)

February 21, 2022

Study Record Updates

Last Update Posted (Actual)

February 21, 2022

Last Update Submitted That Met QC Criteria

February 18, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20220116ZDSYZYJ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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