An Efficacy of Simulator Training for Fiberbronchoscopy in Intensivists

Sponsor

Southeast University, China (Other)

Overall Status

Recruiting

CT.gov ID

NCT05248347

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Simulator Training	Device: Bronchoscopy training simulator LM-092 (Koken Co., Ltd, Tokyo, Japan) Device: The BRONCH Mentor (Simbionix, GI-Bronch Mentor, USA)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

Official Title:

An Efficacy of Simulator Training for Fiberbronchoscopy in Intensivists

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Final score for examination by Bronchoscopy training simulator [through study completion, an average of 3 months]
Final score of manipulation, orientation, anatomy and actual operation

Secondary Outcome Measures

% time at mid-lumen for fiberbronchoscopy manipulation by Bronchoscopy training simulator [through study completion, an average of 3 months]
% time at mid-lumen for fiberbronchoscopy manipulation by Bronchoscopy training simulator
% time at mid-lumen [through study completion, an average of 3 months]
% time at mid-lumen
% time at mid-lumen for fiberbronchoscopy manipulation [through study completion, an average of 3 months]
% time at mid-lumen for fiberbronchoscopy manipulation
Total wall hits for fiberbronchoscopy manipulation by Bronchoscopy training simulator [through study completion, an average of 3 months]
Total wall hits for fiberbronchoscopy manipulation by Bronchoscopy training simulator

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nanjing Zhongda Hospital, Southeast University	Nanjing	Jiangsu	China	210000

Sponsors and Collaborators

Southeast University, China

Investigators

Study Director: Jingyuan Xu, M.D., Southeast University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jingyuan,Xu, Principal Investigator, Southeast University, China

ClinicalTrials.gov Identifier:

NCT05248347

Other Study ID Numbers:

20220116ZDSYZYJ

First Posted:

Feb 21, 2022

Last Update Posted:

Feb 21, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jingyuan,Xu, Principal Investigator, Southeast University, China

Study Results

No Results Posted as of Feb 21, 2022