An Efficacy of Simulator Training for Fiberbronchoscopy in Intensivists

NCT ID: NCT05248347

Last Updated: 2022-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Simulator Training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Bronchoscopy training simulator

Bronchoscopy training simulator LM-092 (Koken Co., Ltd, Tokyo, Japan) was used to train the participants.

Group Type ACTIVE_COMPARATOR

Bronchoscopy training simulator LM-092 (Koken Co., Ltd, Tokyo, Japan)

Intervention Type DEVICE

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.

The BRONCH Mentor

Group B: The BRONCH Mentor (Simbionix, GI-Bronch Mentor, USA) was used.

Group Type EXPERIMENTAL

The BRONCH Mentor (Simbionix, GI-Bronch Mentor, USA)

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Southeast University, China

OTHER

Sponsor Role lead

Responsible Party

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Jingyuan,Xu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jingyuan Xu, M.D.

Role: STUDY_DIRECTOR

Southeast University

Locations

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Nanjing Zhongda Hospital, Southeast University

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Yanjie Zhang

Role: primary

8617854236918

Jingyuan Xu, M.D.

Role: backup

862586232550

Other Identifiers

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20220116ZDSYZYJ

Identifier Type: -

Identifier Source: org_study_id

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